Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genovate Biotechnology Co., Ltd.,
• Treatments: Cilostazol

Criteria

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.