Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | January 2004 |
| End Date: | January 2004 |
A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions
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
conditions.
balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting
conditions.
Inclusion Criteria:
- No clinically significant finding 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 enyzme altering drugs.
- History of allergic or adverse response to balsalazide, mesalamine, salicylates, or
other related drugs.
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