The objective of this study was to assess bioequivalence of a potential generic 750 mg
balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting
- No clinically significant finding on the physical examination, medical history, or
clinical laboratory results during screening.
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enyzme altering drugs.
- History of allergic or adverse response to balsalazide, mesalamine, salicylates, or
other related drugs.