Trials / Completed
CompletedNCT05466734
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Genovate Biotechnology Co., Ltd., · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cilostazol Tablet 100 mg | Two oral doses (total daily dose of 200 mg) |
| DRUG | PMR Tablet 135 mg | Single oral dose (total daily dose of 270 mg) |
Timeline
- Start date
- 2022-07-05
- Primary completion
- 2022-08-23
- Completion
- 2022-09-20
- First posted
- 2022-07-20
- Last updated
- 2023-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05466734. Inclusion in this directory is not an endorsement.