drugset / Trial / NCT03480321
Pharmacokinetic 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 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cilostazol | Small molecule | 100 mg | Oral |
| Comparator | Cilostazol | Small molecule | 300 mg | Oral |
| Comparator | Cilostazol | Small molecule | 400 mg | Oral |