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

NCT ID: NCT03480321

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2018-06-07

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.

Conditions

Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cilostazol 100 mg

Group Type: ACTIVE_COMPARATOR

Cilostazol 100 mg

Intervention Type: DRUG

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)

PMR 150 mg

Group Type: EXPERIMENTAL

PMR 150 mg

Intervention Type: DRUG

Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)

PMR 200 mg

Group Type: EXPERIMENTAL

PMR 200 mg

Intervention Type: DRUG

Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)

Interventions

Cilostazol 100 mg

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)

Intervention Type: DRUG

PMR 150 mg

Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)

Intervention Type: DRUG

PMR 200 mg

Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genovate Biotechnology Co., Ltd.,

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, United States

Countries

United States

Other Identifiers

GBL17-001

Identifier Type: -

Identifier Source: org_study_id