- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167265
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers
An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Saint Petersburg, Florida, United States, 33714
- Cliantha Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be 18 to 50 years of age, inclusive, at screening.
- Absence of diseases that could affect the study outcomes.
- Having a body mass index (BMI) between 18.5 and 29.9 kg/m², inclusive, at screening.
- Women of child-bearing potential must have a negative serum pregnancy test at screening.
- Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.
Exclusion Criteria:
- History of bleeding tendency.
- Use of anticoagulant agent(s) within one (1) month prior to screening.
- Use of tobacco or nicotine products within two (2) weeks of screening.
- Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
- On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
- History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within one (1) year prior to screening.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening.
- Pregnant or breast feeding.
Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
- Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea prior to screening or with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
- Twelve (12) weeks post-surgical bilateral oophorectomy with or without hysterectomy at time of screening, OR;
- Total hysterectomy with absence of menstrual bleeding for a least 3 months prior to screening.
- Acceptable birth control methods are bilateral tubal ligation at least three (3) months prior to screening; copper intrauterine device (paragard) or hormonal intrauterine device in place for at least three (3) months prior to screening and remaining in place until the final study visit; Implantable or Injectable contraceptives in place at least three (3) months prior to screening and remaining in place until the final study visit; Combination hormonal oral contraceptive or contraceptive patch in place three (3) months prior to screening and remaining in place until the final study visit.
- Known or suspected hypersensitivity to any ingredient of the study drug(s).
- Donated blood or lost more than 450 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Treatment RTRT (R: Cilostazol, T: PMR)
Treatment R: One Cilostazol Tablet 100 mg in the morning and another at an interval of 12 hours of the morning dose Treatment T: Two PMR Tablet 145 mg in the morning Four-period dosing following the sequence of Treatment RTRT |
Two oral doses (total daily dose of 200 mg)
Other Names:
Single oral dose (total daily dose of 290 mg)
Other Names:
|
Other: Treatment TRTR (T: PMR, R: Cilostazol)
Treatment R: One Cilostazol Tablet 100 mg in the morning and another at an interval of 12 hours of the morning dose Treatment T: Two PMR Tablet 145 mg in the morning Four-period dosing following the sequence of Treatment TRTR |
Two oral doses (total daily dose of 200 mg)
Other Names:
Single oral dose (total daily dose of 290 mg)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve, from time zero to last measureable time point (AUC 0-t )
Time Frame: 0-72 hours after morning dose
|
0-72 hours after morning dose
|
AUC from time zero to infinity (AUC 0-∞)
Time Frame: 0-72 hours after morning dose
|
0-72 hours after morning dose
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tamatha F. Zemzars, Cliantha Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Intermittent Claudication
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Neuroprotective Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Cilostazol
Other Study ID Numbers
- GBL23-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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