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NCT00618202 Clinical Trial

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Ulcerative Colitis Clinical Trial

Official title:
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00618202
Other study ID # BALS-C750-PVFS-2
Secondary ID
Status Completed
Phase N/A
First received January 30, 2008
Last updated January 19, 2018
Start date May 2005
Est. completion date June 2005

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- No clinically significant abnormal findings 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 enzyme altering drugs.

- History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Balsalazide

Locations
Country Name City State
United States Novum Pharmaceutical Research Services Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, Two Period, 7 day washout
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