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

NCT03480321 | Completed Phase 1 FDA Drug

• 1 other identifier: GBL17-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Peripheral Artery Disease; Cilostazol; PMR; Extended-Release Tablet of Cilostazol

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Cilostazol 100 mg

ACTIVE COMPARATOR

Drug: Cilostazol 100 mg

PMR 150 mg

EXPERIMENTAL

Drug: PMR 150 mg

PMR 200 mg

EXPERIMENTAL

Drug: PMR 200 mg

Interventions

Cilostazol 100 mg 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)

Cilostazol 100 mg

PMR 150 mg DRUG

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

PMR 150 mg

PMR 200 mg DRUG

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

PMR 200 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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;
• 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.
• 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.

Sponsors & Collaborators

• Genovate Biotechnology Co., Ltd.,: lead

Study Sites (1)

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: March 6, 2018
• Primary Completion: April 28, 2018
• Study Completion: June 7, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)