NCT05191862

Bioequivalence Study of PMR Compared to Cilostazol IR 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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Genovate Biotechnology Co., Ltd., · Industry
• Sex: All
• Age: 18 Years – 45 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 100 mg	One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)
DRUG	PMR 135 mg	Two PMR 135 mg at 08:00, single oral dose (total daily dose of 270 mg)

Timeline

• Start date: 2022-04-23
• Primary completion: 2022-05-04
• Completion: 2022-05-07
• First posted: 2022-01-14
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study