NCT03480321

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

An Open-Label, Randomized, Three-Treatment, Three-Way Crossover Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (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 bioequivalency between the test formulations 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 immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg)
DRUG	PMR 150 mg	Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
DRUG	PMR 200 mg	Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)

Timeline

• Start date: 2018-03-06
• Primary completion: 2018-04-28
• Completion: 2018-06-07
• First posted: 2018-03-29
• Last updated: 2018-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study