drugset / Trial / NCT05466734

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

NCT05466734

Phase 1 Completed 25 enrolled Genovate Biotechnology Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2022-07-05
Primary completion
2022-08-23
Completion
2022-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilostazol Small molecule 100 mg Oral
Subject Cilostazol Small molecule 135 mg Oral