Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
- Conditions
- Intermittent Claudication
- Interventions
- Registration Number
- NCT03480321
- Lead Sponsor
- Genovate Biotechnology Co., Ltd.,
- Brief Summary
The study is designed to evaluate the bioequivalency between the test formulations 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Must be 18 to 45 years of age, inclusive.
- Absence of diseases, such as heart failure, significant kidney impairment or a history of restricted blood flow to the heart, that could affect the study outcomes.
- Having a body mass index (BMI) within normal standard limits (18.5~24.9, inclusive).
- Willing and able to give informed consent to participate in the clinical study and comply with all study procedures, restrictions and attend all visits.
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History of bleeding tendency.
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Use of anticoagulant agent(s) within 1 month prior to screening.
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Use of tobacco or nicotine products within 6 months of screening.
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Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization.
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On any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
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History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within 1 year prior to screening.
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Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
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Pregnant or breast feeding.
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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 12 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
- 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
- Using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (e.g. implantable, injectable, vaginal patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
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Known or suspected hypersensitivity to any ingredient of study drug(s).
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Donated blood or lost more than 150 mL of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PMR 150 mg PMR 150 mg - PMR 200 mg PMR 200 mg - Cilostazol 100 mg Cilostazol 100 mg -
- Primary Outcome Measures
Name Time Method Area under the curve, from time zero to last measureable time point (AUC (0-t)) 0-72 hours after morning dose AUC from time zero to infinity (AUC (0-∞)) 0-72 hours after morning dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bio-Kinetic Clinical Applications, LLC
🇺🇸Springfield, Missouri, United States