- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864666
Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
May 13, 2019 updated by: Genovate Biotechnology Co., Ltd.,
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
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Springfield, Missouri, United States, 65802
- Bio-Kinetic Clinical Applications, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be 18 to 45 years of age, inclusive, at screening.
- Absence of diseases that could affect the study outcomes.
- Having a body mass index (BMI) within normal standard limits (18.5 -24.9, inclusive) at screening.
- Females 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 six (6) months 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 with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
- Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
- Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation.
- Known or suspected hypersensitivity to any ingredient of the study drug(s).
- Donated blood or lost more than 150 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Sequence 1
Treatment RTRT
|
One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)
Other Names:
Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 mg)
Other Names:
|
Other: Sequence 2
Treatment TRTR
|
One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)
Other Names:
Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 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
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
March 19, 2019
Study Completion (Actual)
May 3, 2019
Study Registration Dates
First Submitted
March 5, 2019
First Submitted That Met QC Criteria
March 5, 2019
First Posted (Actual)
March 6, 2019
Study Record Updates
Last Update Posted (Actual)
May 14, 2019
Last Update Submitted That Met QC Criteria
May 13, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- 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
- GBL18-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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