drugset / Trial / NCT03480321

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

NCT03480321

Phase 1 Completed 21 enrolled Genovate Biotechnology Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2018-03-06
Primary completion
2018-04-28
Completion
2018-06-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cilostazol Small molecule 100 mg Oral
Comparator Cilostazol Small molecule 300 mg Oral
Comparator Cilostazol Small molecule 400 mg Oral