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.
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
- 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