NCT06167265

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

An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Genovate Biotechnology Co., Ltd., · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2023-11-28
• Primary completion: 2023-12-22
• Completion: 2024-01-18
• First posted: 2023-12-12
• Last updated: 2024-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study