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Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions | Clinical Trials | Clareo Health

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Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions

NCT00618228•Roxane Laboratories

View on ClinicalTrials.gov

Summary

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.

Eligibility

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.

Locations (1)

Novum Pharmaceuticals Research Services

Houston, Texas, United States

Key Dates

Start Date

January 1, 2004

Primary Completion Date

January 1, 2004

Completion Date

January 1, 2004

Last Updated

January 23, 2018

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

Balsalazide

DRUG

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

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Ulcerative Colitis

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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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: March 29, 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.

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Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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