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

Intermittent Claudication Clinical Trial

Official title:

An Open-Label, Randomized, Three-Treatment, Three-Way Crossover Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480321
• Other study ID #: GBL17-001
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2018
• Est. completion date: June 7, 2018

Study information

• Verified date: July 2018
• Source: Genovate Biotechnology Co., Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 7, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Drug:
• 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)
• PMR 150 mg
Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
• PMR 200 mg
Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications, LLC	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Genovate Biotechnology Co., Ltd.,

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve, from time zero to last measureable time point (AUC (0-t))		0-72 hours after morning dose
Primary	AUC from time zero to infinity (AUC (0-8))		0-72 hours after morning dose