Expired Study
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Houston, Texas 77042


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.


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.


Study is Available At:


Original ID:

BALS-02


NCT ID:

NCT00618228


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions


Official Title:

A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

West-Ward Pharmaceutical


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

52


Enrollment Type:

Actual


Overall Contact Information

Official Name:So Ran Hong, M.D>
Principal Investigator
Novum Pharmaceutical Research Services

Study Dates

Start Date:January 2004
Completion Date:January 2004
Completion Type:Actual
Primary Completion Date:January 2004
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 19, 2018
First Received Date:January 30, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Time Frame:Baseline, Two period, 7 day washout
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Balsalazide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Roxane Laboratories

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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