- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07663318
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)
A Phase 1, Single-center, Open-Label, Randomized, Three-Period, Six-Sequence, Single-Dose, Crossover Study in Healthy Participants Under Fasted or Fed Condition to Compare the Relative Bioavailability of Orally Administrated Octreotide Acetate Tablets (T25) and Orally Administrated Octreotide Acetate Delayed-Release Capsules (MYCAPSSA®) and to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25
The goal of this clinical trial] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are:
- How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa?
- What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet?
Participants will:
Take T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7~14 days after the last dose of investigational product via phone/message/WeChat or in face-to-face manner.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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-
Shandong
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Zibo, Shandong, China
- Zibo Central Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Healthy male or female aged 18 to 55 years (both inclusive).
- Participants with a body mass index (BMI, weight [kg]/height2 [m2]) within 19-28 kg/m2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female.
- Participants with good physical condition, without any history of disease or clinically relevantly abnormal vital signs or physical examination. Participants in good general health, without clinically significant physical examination, vital signs, laboratory tests, ECGs, or abdominal ultrasound findings at Screening or Check-in (Day -2) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- Participants with childbearing potential must agree to use adequate contraception and have no plan for pregnancy from screening period throughout 3 months after the last dose of investigational product; Women of childbearing potential (WOCBP) must have a negative blood pregnancy test prior to the first dose of investigational products. Note: WOCBP are defined as females who have reached menarche but have not yet undergone menopause (defined as ≥12 consecutive months of amenorrhea for non-pathological reasons) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
- Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures.
- Participants with high compliance for all protocol requirements.
Exclusion Criteria:
- Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage.
- Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test.
- Participants with a history of chronic or severe diseases involving the cardiovascular, hepatic, renal, gall biliary, respiratory, hematologic/lymphatic, endocrine, immune, psychiatric, neuromuscular, or GI systems from one year prior to the first dose of study drug; or with a history (or a current condition) of GI disorders during this period, such as chronic or active upper GI diseases (e.g., esophageal disorders, gastritis, duodenitis, peptic ulcers), active GI bleeding, or history of GI surgery, as determined by the Investigator, may impact the ability of the subject to participate or potentially confound the study results.
- Participants who have received a radiation dose exceeding 5 mSv within the past 12 months (e.g., more than 2 cranial CT scans [approximately 2 mSv per scan], more than 3 low-dose chest CT scans [approximately 1.5 mSv per scan], more than 1 standard chest CT scan [4-7 mSv per scan], or more than 1 abdominal CT scan [8 mSv per scan]), or have received a total radiation dose over 10 mSv in the preceding 5 years, or are scheduled to undergo additional radiological examinations during the trial or within one year after the completion of the trial.
- AST > ULN or bilirubin > ULN.
- Creatinine clearance <90 mL/min during screening (calculation formula of Creatinine Clearance is detailed in Section 8.2.1.6).
- Participants with a history or presence of hypothyroidism.
- Participants with a history of drug abuse within 5 years or intake of any narcotics within 6 months before the initial administration, or who have a positive drug abuse test on admission.
- Participants with a history of alcohol abuse within 6 months before the initial administration, defined as an average alcohol intake > 2 units/day (1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).
- Participants with a history of smoking > 5 cigarettes/day within 3 months before the initial administration or unable to refrain from using any tobacco or nicotine-containing product within 48 hours prior to administration and during hospitalization.
- Participants who have donated or lost blood > 400 mL within 3 months before the initial administration.
- Participants who have received major surgery or hospitalized within 3 months before the initial administration.
- Participants who have received investigational drugs or participated in other clinical trials within 3 months before the initial administration.
- Participants who have received prescription drug within 14 days before the initial administration.
- Participants who have taken high-density medications such as bismuth agents and calcium agents within 7 days before the initial administration.
- Participants who have received over the counter (OTC) drug or herb within 7 days before the initial administration.
- Participants who have consumed grapefruit juice, or other food or beverage containing caffeine or xanthine within 7 days before the initial administration.
- Participants who have drunk alcohol within 48 hours before the initial administration or with a positive breath alcohol test (> 0 mg/100 mL).
- Participants cannot receive standard meals during the study.
- Participants who cannot tolerate venipuncture or have a history of fear of needles or hemophobia.
- Participants with vitamin B12 deficiency.
- Participants with acute minor diseases (common cold, diarrhea, etc.) during screening.
- For female participants, breastfeeding or positive for pregnancy test at screening, or who have unprotected sexual contact within 2 weeks before dosing, or who have intrauterine devices in their bodies.
- Participants who are not suitable for participating in this study due to other reasons as judged by Investigator.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: T25-Fast
T25 administrated in fast state
|
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
|
|
Experimental: T25 -Fed
T25 administrated in fed state
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Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state
|
|
Comparador Ativo: mycapssa
Mycapssa administrated in fast state
|
Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
bioavailability
Prazo: From time 0 (administration) to 24 hours post-administration
|
The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)
|
From time 0 (administration) to 24 hours post-administration
|
|
bioavailability
Prazo: From time 0 (administration) to 24 hours post-administration
|
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax
|
From time 0 (administration) to 24 hours post-administration
|
|
bioavailability
Prazo: From time 0 (administration) to 24 hours post-administration.
|
The ratio of geometric least square means between the T25 and MYCAPSSA® for area under the concentration-time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast) .
Sampling (Fasted condition) occurs at the following timepoints: 0 (pre-dose) , 0.5 , 1.0, 1.33 , 1.67 , 2.0 , 2.33 , 2.67 , 3.0 , 3.33 , 3.67 , 4.0 , 4.5 , 5.0 , 5.5 , 6.0 , 7.0, 8.0, 9.0, 10.0, 12.0,14.0,
16.0, 24.0 hour post-dose.
|
From time 0 (administration) to 24 hours post-administration.
|
|
bioavailability
Prazo: From 0 (administration) to 24hour
|
The ratio of geometric least square means between the T25 and MYCAPSSA® for AUC from time zero to infinity (AUC0-inf) via dose normalization.
AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
It is obtained from AUC (0-t) plus AUC (t-inf)
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From 0 (administration) to 24hour
|
|
bioavailability
Prazo: From time 0 (administration) to 24 hours post-administration.
|
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC0-tlast (sampling occurs at the following timepoints: Fasted condition: 0 (pre-dose) , 0.5 , 1.0, 1.33, 1.67, 2.0, 2.33, 2.67, 3.0, 3.33, 3.67, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0,14.0,
16.0, 24.0 hour post-dose; Fed condition: 0 (pre-dose), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 , 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 , 11.0, 12.0, 14.0, 16.0, 24.0 hour post-dose;)
|
From time 0 (administration) to 24 hours post-administration.
|
|
bioavailability
Prazo: From time 0 (administration) to 24hour.
|
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC from time zero to infinity (AUC0-inf).AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
It is obtained from AUC (0-t) plus AUC (t-inf)
|
From time 0 (administration) to 24hour.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PK profile (Tlag)
Prazo: From time 0 (administration) to 24 hours post-administration
|
the first observation with a measurable (non-zero) concentration (Tlag)
|
From time 0 (administration) to 24 hours post-administration
|
|
PK profile(Tmax)
Prazo: From time 0 (administration) to 24 hours post-administration
|
time to reach maximum plasma concentration
|
From time 0 (administration) to 24 hours post-administration
|
|
PK profile(t₁/₂)
Prazo: From time 0 (administration) to 24 hours post-administration
|
elimination half-life (t₁/₂)
|
From time 0 (administration) to 24 hours post-administration
|
|
PK profile(Kel)
Prazo: From time 0 (administration) to 24 hours post-administration
|
elimination rate constant
|
From time 0 (administration) to 24 hours post-administration
|
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PK profile(CL/F)
Prazo: From time 0 (administration) to 24 hours post-administration
|
apparent total clearance after oral administration
|
From time 0 (administration) to 24 hours post-administration
|
|
PK profile(Vz/F)
Prazo: From time 0 (administration) to 24 hours post-administration
|
apparent volume of distribution after oral administration
|
From time 0 (administration) to 24 hours post-administration
|
|
PK profile(AUC_%Extrap)
Prazo: From time 0 (administration) to 24 hours post-administration
|
percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration
|
From time 0 (administration) to 24 hours post-administration
|
|
the gastrointestinal transit of T25 using an abdominal X-ray
Prazo: Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.
|
the abdominal X-ray
|
Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.
|
|
the gastrointestinal transit of T25 using an abdominal X-ray
Prazo: Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.
|
the abdominal X-ray
|
Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.
|
|
Safety and tolerability - number and severity of adverse events
Prazo: From the first dose until 7 days after the last dose
|
Incidence and severity of AE
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability -Temperature (ear)
Prazo: From the first dose until 7 days after the last dose
|
Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear)
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability - Blood pressure
Prazo: From the first dose until 7 days after the last dose
|
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability -Pulse
Prazo: From the first dose until 7 days after the last dose
|
Incidence of Adverse Events and Abnormalities as assessed by pulse
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability - Physical examination
Prazo: From the first dose until 7 days after the last dose
|
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability - clinical laboratory tests
Prazo: From the first dose until 7 days after the last dose
|
Number of abnormalities assessed based on safety bloods and urine test( hematology, blood biochemistry, coagulation function, urinalysis, thyroid function, serum vitamin B12, serum pregnancy test (only for females), etc)
|
From the first dose until 7 days after the last dose
|
|
Safety and tolerability - ECG
Prazo: From the first dose until 7 days after the last dose
|
Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval
|
From the first dose until 7 days after the last dose
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças ósseas
- Doenças musculoesqueléticas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças hipotalâmicas
- Hiperpituitarismo
- Doenças da Hipófise
- Doenças Ósseas Endócrinas
- Acromegalia
- Peptídeos
- Aminoácidos, peptídeos e proteínas
- Compostos policíclicos
- Compostos macrocíclicos
- Peptídeos, cíclicos
- Octreotida
Outros números de identificação do estudo
- T25-101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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