A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | May 2005 |
| End Date: | June 2005 |
The objective of this study was to assess the 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, administered under
fasting conditions.
balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under
fasting conditions.
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 balsalazide, mesalamine, salicylates, or
other related drugs.
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