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

Roxane Laboratories52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

BalsalazideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No clinically significant abnormal findings 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 enzyme altering drugs. * History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.

Locations (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two Period, 7 day washout

Data from ClinicalTrials.gov

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