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

Completed · Not applicable

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00618202

Run by

Roxane Laboratories

People needed

52

Starts

2005-05-01

Expected to finish

2005-06-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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