Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Not Applicable

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00618228
• Lead Sponsor: Roxane Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-18
• Study First Posted: 2008-02-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two period, 7 day washout

Trial Locations

Locations (1)

Novum Pharmaceuticals Research Services; 🇺🇸 Houston, Texas, United States