Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618228

Enrollment

Registered

2008-02-19

Start date

2004-01-31

Completion date

2004-01-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

DRUGBalsalazide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, Two period, 7 day washout

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026