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COMPLETEDNANCT00618228

Bioequivalency Study of 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...

Lead sponsor: Roxane Laboratories•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Roxane Laboratories

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 23, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment52

Start dateJan 2004

Last updatedJan 23, 2018

Condition

Ulcerative Colitis

Locations shown

Novum Pharmaceuticals Research Services

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions