Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Angina, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | April 2004 |
| End Date: | May 2004 |
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine
Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence 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 Amlodipine Besylate or any comparable or
similar product.
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