Intermittent Claudication
Conditions
Keywords
Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol
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.
Interventions
One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg)
DRUGPMR 150 mg
Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
DRUGPMR 200 mg
Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)
Sponsors
Genovate Biotechnology Co., Ltd.,
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* History of bleeding tendency. * Use of anticoagulant agent(s) within 1 month prior to screening. * Use of tobacco or nicotine products within 6 months of screening. * Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization. * 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). * History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within 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); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 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: 1. 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; 2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR; 3. 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. * Known or suspected hypersensitivity to any ingredient of study drug(s). * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed