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

NCT03864666 | Completed Phase 1 FDA Drug

• 1 other identifier: GBL18-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation 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 (2)

Sequence 1

OTHER

Treatment RTRT

Drug: Cilostazol 100 mg; Drug: PMR 200 mg

Sequence 2

OTHER

Treatment TRTR

Drug: Cilostazol 100 mg; Drug: PMR 200 mg

Interventions

Cilostazol 100 mg DRUG

One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)

Also known as: Treatment R

Sequence 1; Sequence 2

PMR 200 mg DRUG

Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 mg)

Also known as: Treatment T

Sequence 1; Sequence 2

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, at screening.
• Absence of diseases that could affect the study outcomes.
• Having a body mass index (BMI) within normal standard limits (18.5 -24.9, inclusive) at screening.
• Females must have a negative serum pregnancy test at screening.
• Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.

You may not qualify if:

• History of bleeding tendency.
• Use of anticoagulant agent(s) within one (1) month prior to screening.
• Use of tobacco or nicotine products within six (6) months of screening.
• Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
• On any investigational drug(s) or therapeutic device(s) within thirty (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 one (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); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (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 twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40IU/L, OR;
• Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
• Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation.
• Known or suspected hypersensitivity to any ingredient of the study drug(s).
• Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (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, 2019
• First Posted: March 6, 2019
• Study Start: February 11, 2019
• Primary Completion: March 19, 2019
• Study Completion: May 3, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

US (1)