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Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618228
Recruitment Status : Completed
First Posted : February 19, 2008
Last Update Posted : January 23, 2018
Information provided by:
West-Ward Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Balsalazide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions
Study Start Date : January 2004
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, Two period, 7 day washout ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00618228

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United States, Texas
Novum Pharmaceuticals Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
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Principal Investigator: So Ran Hong, M.D> Novum Pharmaceutical Research Services

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Responsible Party: Elizabeth Ernst/Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. Identifier: NCT00618228     History of Changes
Other Study ID Numbers: BALS-02
First Posted: February 19, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents