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McKesson
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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR BALSALAZIDE DISODIUM

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Clinical Trials for Balsalazide Disodium

Trial ID Title Status Sponsor Phase Summary
NCT00269438 New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis Completed Valeant Pharmaceuticals International, Inc. Phase 3 The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.
NCT00408174 Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis Completed Valeant Pharmaceuticals International, Inc. Phase 3 To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.
NCT00486031 Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study Completed Valeant Pharmaceuticals International, Inc. Phase 3 The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
NCT00618202 A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions Completed Roxane Laboratories N/A 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.
NCT00618228 Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions Completed Roxane Laboratories N/A 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.
NCT00648531 Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting conditions.
NCT00649480 Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Balsalazide Disodium

Condition Name

Condition Name for Balsalazide Disodium
Intervention Trials
Ulcerative Colitis 5
Inflammatory Bowel Disease 2
Healthy 2
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Condition MeSH

Condition MeSH for Balsalazide Disodium
Intervention Trials
Colitis, Ulcerative 5
Ulcer 3
Colitis 3
Inflammatory Bowel Diseases 2
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Clinical Trial Locations for Balsalazide Disodium

Trials by Country

Trials by Country for Balsalazide Disodium
Location Trials
United States 90
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Trials by US State

Trials by US State for Balsalazide Disodium
Location Trials
Texas 5
Iowa 3
Virginia 3
Tennessee 3
California 3
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Clinical Trial Progress for Balsalazide Disodium

Clinical Trial Phase

Clinical Trial Phase for Balsalazide Disodium
Clinical Trial Phase Trials
Phase 3 3
Phase 1 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for Balsalazide Disodium
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for Balsalazide Disodium

Sponsor Name

Sponsor Name for Balsalazide Disodium
Sponsor Trials
Valeant Pharmaceuticals International, Inc. 3
Mylan Pharmaceuticals 2
Roxane Laboratories 2
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Sponsor Type

Sponsor Type for Balsalazide Disodium
Sponsor Trials
Industry 7
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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Dow
Merck
Johnson and Johnson
Moodys
Teva
Argus Health
Covington
Fish and Richardson

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