drugset / Trial / NCT06167265

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

NCT06167265

Phase 1 Completed 40 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
2023-11-28
Primary completion
2023-12-22
Completion
2024-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilostazol Small molecule 100 mg Oral
Subject Cilostazol Small molecule 145 mg Oral