Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

This study has been completed.

First Received: January 30, 2008 Last Updated: February 18, 2008 History of Changes

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00618228

Purpose

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	Intervention
Ulcerative Colitis	Drug: Balsalazide

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Balsalazide Balsalazide disodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, 7 day washout ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	January 2004
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618228

Locations

United States, Texas
Novum Pharmaceuticals Research Services
Houston, Texas, United States, 77042

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

So Ran Hong, M.D>

Novum Pharmaceutical Research Services

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst/Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	BALS-02
Study First Received:	January 30, 2008
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00618228 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Balsalazide
Intestinal Diseases

Digestive System Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Gastrointestinal Agents
Inflammatory Bowel Diseases
Colitis, Ulcerative
Balsalazide
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents
Colitis

ClinicalTrials.gov processed this record on May 07, 2009