Status:
COMPLETED
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 cap...
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00618202
Start Date
May 1 2005
End Date
June 1 2005
Last Update
January 23 2018
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042