Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg

This open-label, single dose, randomized, two-period, two-treatment, two-sequence, crossover study was conducted to investigate the bioequivalence of two formulations of balsalazide disodium 750 mg capsules under non-fasting conditions. The study was conducted with 60 (60 completing) healthy adults in accordance with Protocol No. BALS-06128 (Version 22 December 2006). In each study period, a single, oral 2250 mg dose (3 x 750 mg capsules) was administered to all subjects following an overnight fast of at least 10 hours. The test formulation was Mylan Pharmaceuticals Inc.'s Balsalazide Disodium Capsules, 750 mg and the reference formulation was Colazal® 750 mg capsules (manufactured for Salix Pharmaceuticals, Inc.). The subjects received the test product in one study period and the reference product in the other study period. Drug administration occurred according to the dosing randomization schedule (see Appendix 16.1.7). There was a 7-day washout interval between treatments.