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

NCT ID: NCT05466734

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2022-09-20

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

Study Design

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

Study Groups

Treatment RTRT (R: Cilostazol, T: PMR)

Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00

Treatment T: Two PMR Tablet 135 mg at 08:00

Four-period dosing following the sequence of Treatment RTRT

Group Type: OTHER

Cilostazol Tablet 100 mg

Intervention Type: DRUG

Two oral doses (total daily dose of 200 mg)

PMR Tablet 135 mg

Intervention Type: DRUG

Single oral dose (total daily dose of 270 mg)

Treatment TRTR (T: PMR, R: Cilostazol)

Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00

Treatment T: Two PMR Tablet 135 mg at 08:00

Four-period dosing following the sequence of Treatment TRTR

Group Type: OTHER

Cilostazol Tablet 100 mg

Intervention Type: DRUG

Two oral doses (total daily dose of 200 mg)

PMR Tablet 135 mg

Intervention Type: DRUG

Single oral dose (total daily dose of 270 mg)

Interventions

Cilostazol Tablet 100 mg

Two oral doses (total daily dose of 200 mg)

Intervention Type: DRUG

PMR Tablet 135 mg

Single oral dose (total daily dose of 270 mg)

Intervention Type: DRUG

Other Intervention Names

Treatment R; Treatment T

Eligibility Criteria

Inclusion Criteria

• 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) between 18.5 and 29.9, 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.

Exclusion Criteria

• 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.
• Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at any time during the study, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19).
• 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 twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;

2. Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;

3. 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.

• 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

Principal Investigators

Kayce Morton

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications, LLC

Locations

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, United States

Countries

United States

Other Identifiers

GBL22-001

Identifier Type: -

Identifier Source: org_study_id