Safety, Tolerability, and Pharmacokinetics of DM1001 Transdermal Patch in Healthy Chinese Participants
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of the DM1001 Transdermal Patch in Healthy Chinese Participants
This is a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the DM1001 transdermal patch in healthy Chinese participants. Eligible participants will receive DM1001 according to the clinical trial protocol. Safety, tolerability, and pharmacokinetic assessments will be conducted at prespecified time points during the study. The study is intended to provide initial information on the safety, tolerability, and pharmacokinetic characteristics of DM1001 in humans.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase 1 registration drug clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of the DM1001 transdermal patch in healthy Chinese participants.
The investigational product is the DM1001 transdermal patch. The study will be conducted according to the approved clinical trial protocol. In China, the study is classified as a Class 2.2 chemical drug clinical trial.
The study will evaluate the safety and tolerability of DM1001 and characterize its pharmacokinetic properties during the clinical trial. Safety, tolerability, and pharmacokinetic assessments will be performed according to the procedures and time points specified in the clinical trial protocol.
The study is being conducted by the Phase I Clinical Research Unit of the Third Xiangya Hospital of Central South University. The principal investigators are Guoping Yang and Chengxian Guo.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Criterion 1. Healthy male or female participants aged 18 to 55 years, inclusive, at the time of informed consent.
- Criterion 2. Body weight of at least 50 kg for males and at least 45 kg for females.
- Criterion 3. BMI between 18 and 28 kg/m², inclusive.
- Criterion 4. Able to understand the study procedures and potential risks, provide written informed consent, communicate effectively with the investigator, and comply with all study requirements.
Exclusion Criteria:
- Criterion 1. Clinically significant disease or dysfunction, including neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, renal, metabolic, endocrine, dermatological, hematological, immunological, or malignant disease.
- Criterion 2. Any condition or history of surgery that may affect drug absorption, distribution, metabolism, or excretion, or may place the participant at unacceptable risk.
- Criterion 3. Significant history of drug or skin allergy, or known allergy to any study intervention component.
- Criterion 4. Current or previous psychiatric or brain disorder, suicide risk according to the Columbia-Suicide Severity Rating Scale, or history of self-harm.
- Criterion 5. History of drug or substance abuse, positive urine drug screen, alcohol abuse, or positive alcohol breath test.
- Criterion 6. Smoking of 5 or more cigarettes per day or consumption of 5 or more cups of coffee or tea per day within the specified period, or inability to discontinue these activities during the study.
- Criterion 7. Unhealed skin disease or unsuitable application sites, including excessive hair, sunburn, raised moles, scars, wounds, tattoos, abnormal pigmentation, excessive sweating, or other conditions that may interfere with patch application or skin assessment.
- Criterion 8. Pregnancy or breastfeeding, positive pregnancy test, plans for pregnancy during the study or within 6 months after the study, or unwillingness to use effective contraception.
- Criterion 9. Clinically significant abnormalities in physical examination, vital signs, laboratory tests, chest imaging, ultrasound, or electrocardiogram, including QTcF of 450 ms or greater in males or 460 ms or greater in females.
- Criterion 10. Resting pulse rate below 55 or above 100 beats per minute, systolic blood pressure below 90 or at least 140 mmHg, or diastolic blood pressure below 60 or at least 90 mmHg.
- Criterion 11. Positive test results for HBsAg, HCV antibody, HIV antibody, or syphilis testing.
- Criterion 12. ALT or creatinine above the upper limit of normal, or serum prolactin greater than twice the upper limit of normal.
- Criterion 13. Blood donation or blood loss meeting the protocol-defined limits, recent surgery, use of any medication within 2 weeks before study dosing, participation in another clinical trial within 3 months, or vaccination within 30 days.
- Criterion 14. Any other condition, poor compliance, or circumstance that, in the investigator's judgment, makes the participant unsuitable for the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: DM1001 Transdermal Patch
Participants receive DM1001 transdermal patch in Cohorts 1, 3, 4, 5, and 6. Doses include 2.8 mg, 5.6 mg, and 11.2 mg according to the cohort-specific schedule. The patch is applied to the upper arm, upper back, or outer thigh according to the cohort. Cohorts 1 and 3 are randomized in a 3:1 ratio to DM1001 or matching placebo, whereas Cohorts 4, 5, and 6 are open-label. |
DM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites. |
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Comparador de placebos: Matching Placebo Transdermal Patch
Participants in Cohorts 1 and 3 receive matching placebo transdermal patch according to the randomized, double-blind, placebo-controlled design. Participants are randomized in a 3:1 ratio to DM1001 or matching placebo. |
Matching placebo transdermal patch containing 0 mg per 10 cm2, administered in Cohorts 1 and 3 according to the randomized, double-blind study design. |
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Comparador activo: Pramipexole Extended-Release Tablet
Participants in Cohort 2 receive oral pramipexole extended-release tablets at 0.375 mg once daily during Week 1, 0.75 mg once daily during Week 2, and 1.5 mg once daily during Week 3. |
Oral pramipexole extended-release tablets administered at 0.375 mg, 0.75 mg, and 1.5 mg once daily during Weeks 1, 2, and 3, respectively. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Study Withdrawal
Periodo de tiempo: From first administration through the end of safety follow-up, up to Day 11, Day 24, Day 25, or Day 46 depending on the cohort.
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Incidence, severity, seriousness, and relationship to study intervention, including changes in vital signs, physical examination, 12-lead ECG, hematology, urinalysis, clinical chemistry, coagulation, and prolactin. |
From first administration through the end of safety follow-up, up to Day 11, Day 24, Day 25, or Day 46 depending on the cohort.
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Maximum Observed Plasma Concentration (Cmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Cmax derived from observed plasma pramipexole concentration-time data following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Time to Maximum Observed Plasma Concentration (Tmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Tmax derived from observed plasma pramipexole concentration-time data following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Terminal Elimination Rate Constant (Lambda z) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Lambda z is the terminal elimination rate constant of pramipexole estimated from the terminal log-linear portion of the plasma concentration-time curve following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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The apparent terminal elimination half-life is the time required for the plasma concentration of pramipexole to decrease by one-half during the terminal elimination phase following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Pramipexole Following DM1001 Transdermal Patch Administration.
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC0-t is the area under the plasma pramipexole concentration-time curve from time zero to the time of the last quantifiable plasma concentration following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC0-inf is the total area under the plasma pramipexole concentration-time curve from time zero extrapolated to infinity following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Total Clearance (CL/F) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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CL/F is the apparent total clearance of pramipexole from plasma following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Volume of Distribution (Vd/F) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Mean Residence Time (MRT) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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MRT is the estimated average time that pramipexole remains in the body following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC%Extrap is the percentage of AUC0-inf attributable to extrapolation from the last quantifiable plasma concentration to infinity following administration of the DM1001 transdermal patch. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Css,max is the highest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Time to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Tss,max is the elapsed time from administration to the maximum observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Css,min is the lowest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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AUCss is the area under the plasma pramipexole concentration-time curve over one dosing interval at steady state following administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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RAUC is the accumulation ratio of pramipexole calculated by comparing the area under the plasma concentration-time curve at steady state with the corresponding area under the curve after the initial administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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RCmax is the accumulation ratio of pramipexole calculated by comparing the maximum observed plasma concentration at steady state with the maximum observed plasma concentration after the initial administration of the DM1001 transdermal patch. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Maximum Observed Plasma Concentration (Cmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From pre-dose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Cmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets. |
From pre-dose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Time to Maximum Observed Plasma Concentration (Tmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Tmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Terminal Elimination Rate Constant (Lambda z) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
|
Lambda z is the terminal elimination rate constant of pramipexole estimated from the terminal log-linear portion of the plasma concentration-time curve following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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The apparent terminal elimination half-life is the time required for the plasma concentration of pramipexole to decrease by one-half during the terminal elimination phase following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration.
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC0-t is the area under the plasma pramipexole concentration-time curve from time zero to the time of the last quantifiable plasma concentration following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC0-inf is the total area under the plasma pramipexole concentration-time curve from time zero extrapolated to infinity following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Total Clearance (CL/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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CL/F is the apparent total clearance of pramipexole from plasma following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Apparent Volume of Distribution (Vd/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Mean Residence Time (MRT) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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MRT is the estimated average time that pramipexole remains in the body following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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AUC%Extrap is the percentage of AUC0-inf attributable to extrapolation from the last quantifiable plasma concentration to infinity following administration of oral pramipexole extended-release tablets. |
From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Css,max is the highest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Time to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Tss,max is the elapsed time from administration to the maximum observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Css,min is the lowest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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AUCss is the area under the plasma pramipexole concentration-time curve over one dosing interval at steady state following administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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RAUC is the accumulation ratio of pramipexole calculated by comparing the area under the plasma concentration-time curve at steady state with the corresponding area under the curve after the initial administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Periodo de tiempo: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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RCmax is the accumulation ratio of pramipexole calculated by comparing the maximum observed plasma concentration at steady state with the maximum observed plasma concentration after the initial administration of oral pramipexole extended-release tablets. |
From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Skin Irritation at the Application Site Assessed Using the Predefined Skin Reaction Score
Periodo de tiempo: Before patch application and at 1, 24, and 48 hours after patch removal; assessment may be extended to Day 7 or Day 14 if necessary.
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Number of participants with skin irritation at the patch application and control sites, assessed using the predefined skin reaction score (range 0-7) and other effect categories (A-H). The number and percentage of participants in each score category will be reported. |
Before patch application and at 1, 24, and 48 hours after patch removal; assessment may be extended to Day 7 or Day 14 if necessary.
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Mean DM1001 Patch Adhesion Score at Each Scheduled Assessment
Periodo de tiempo: Within 1 hour after each patch application and at 12, 24, and every 24 hours thereafter through patch removal at 168 hours.
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Patch adhesion assessed at 0, 12, and 24 hours after application and every 24 hours thereafter until patch removal. |
Within 1 hour after each patch application and at 12, 24, and every 24 hours thereafter through patch removal at 168 hours.
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Mean Transdermal Absorption Percentage of Pramipexole From DM1001 Patches Based on Residual Drug Content
Periodo de tiempo: Assessed at each scheduled patch removal (168 hours after application): Day 8 for Cohorts 1, 5, and 6; Days 8, 15, and 22 for Cohort 3; and Days 8, 15, 22, 29, 36, and 43 for Cohort 4.
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Used DM1001 patches will be collected at each scheduled patch removal. The transdermal absorption percentage of pramipexole from each patch will be derived from the residual drug content measured in the used patch using the prespecified calculation method. |
Assessed at each scheduled patch removal (168 hours after application): Day 8 for Cohorts 1, 5, and 6; Days 8, 15, and 22 for Cohort 3; and Days 8, 15, 22, 29, 36, and 43 for Cohort 4.
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Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DM1001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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