Expired Study
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Houston, Texas 77042


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00618228


Primary Contact:

Principal Investigator
So Ran Hong, M.D>
Novum Pharmaceutical Research Services


Backup Contact:

N/A


Location Contact:

Houston, Texas 77042
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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