Overview

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

Status:
Completed

Trial end date:
2005-06-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

N/A

Details

Lead Sponsor:

Roxane Laboratories

Treatments:

Balsalazide
Mesalamine