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

NCT06167265 | Completed Phase 1 FDA Drug

• 1 other identifier: GBL23-001
• Study Type: interventional
• Target: 40
• 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)

Treatment RTRT (R: Cilostazol, T: PMR)

OTHER

Treatment R: One Cilostazol Tablet 100 mg in the morning and another at an interval of 12 hours of the morning dose Treatment T: Two PMR Tablet 145 mg in the morning Four-period dosing following the sequence of Treatment RTRT

Drug: Cilostazol Tablet 100 mg; Drug: PMR Tablet 145 mg

Treatment TRTR (T: PMR, R: Cilostazol)

OTHER

Treatment R: One Cilostazol Tablet 100 mg in the morning and another at an interval of 12 hours of the morning dose Treatment T: Two PMR Tablet 145 mg in the morning Four-period dosing following the sequence of Treatment TRTR

Drug: Cilostazol Tablet 100 mg; Drug: PMR Tablet 145 mg

Interventions

Cilostazol Tablet 100 mg DRUG

Two oral doses (total daily dose of 200 mg)

Also known as: Treatment R

Treatment RTRT (R: Cilostazol, T: PMR); Treatment TRTR (T: PMR, R: Cilostazol)

PMR Tablet 145 mg DRUG

Single oral dose (total daily dose of 290 mg)

Also known as: Treatment T

Treatment RTRT (R: Cilostazol, T: PMR); Treatment TRTR (T: PMR, R: Cilostazol)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be 18 to 50 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 kg/m², inclusive, at screening.
• Women of child-bearing potential 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 two (2) weeks 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 prior to screening or with serum Follicle Stimulating Hormone (FSH) levels \> 40IU/L, OR;
• Twelve (12) weeks post-surgical bilateral oophorectomy with or without hysterectomy at time of screening, OR;
• Total hysterectomy with absence of menstrual bleeding for a least 3 months prior to screening.
• Acceptable birth control methods are bilateral tubal ligation at least three (3) months prior to screening; copper intrauterine device (paragard) or hormonal intrauterine device in place for at least three (3) months prior to screening and remaining in place until the final study visit; Implantable or Injectable contraceptives in place at least three (3) months prior to screening and remaining in place until the final study visit; Combination hormonal oral contraceptive or contraceptive patch in place three (3) months prior to screening and remaining in place until the final study visit.
• Known or suspected hypersensitivity to any ingredient of the study drug(s).
• Donated blood or lost more than 450 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)

Cliantha Research

St. Petersburg, Florida, 33714, 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 Officials

• Tamatha F. Zemzars

  Cliantha Research

  PRINCIPAL INVESTIGATOR

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: December 4, 2023
• First Posted: December 12, 2023
• Study Start: November 28, 2023
• Primary Completion: December 22, 2023
• Study Completion: January 18, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)