drugset / Trial / NCT00649480

Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg

NCT00649480

Phase 1 Completed 60 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

Timeline

Start
2007-01
Primary completion
2007-02
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Balsalazide Small molecule 2250 mg Oral

Indications

No indication recorded.