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

Roxane Laboratories

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: Balsalazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618202

BALS-C750-PVFS-2

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)