drugset / Trial / NCT05466734
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cilostazol | Small molecule | 100 mg | Oral |
| Subject | Cilostazol | Small molecule | 135 mg | Oral |