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

NCT06167265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

DRUG

Cilostazol Tablet 100 mg

Two oral doses (total daily dose of 200 mg)

DRUG

PMR Tablet 145 mg

Single oral dose (total daily dose of 290 mg)

Sponsors & Collaborators

  • Genovate Biotechnology Co., Ltd.,

    lead INDUSTRY

Principal Investigators

  • Tamatha F. Zemzars · Cliantha Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2023-12-22
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167265 on ClinicalTrials.gov