Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Roxane Laboratories

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Drug: Balsalazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00618228

BALS-02

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.