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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00618202 |
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.
Condition | Intervention |
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Ulcerative Colitis |
Drug: Balsalazide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 |
Principal Investigator: | So Ran Hong, M.D. | Novum Pharmaceutical Research Services |
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | BALS-C750-PVFS-2 |
Study First Received: | January 30, 2008 |
Last Updated: | February 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00618202 |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Balsalazide Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |