Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | February 2004 |
| End Date: | March 2004 |
A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol
Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions
using a single-dose, randomized, 2-treatment, 2-period, crossover design.
Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions
using a single-dose, randomized, 2-treatment, 2-period, crossover design.
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to Cilostazol or any comparable or similar
product.
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