drugset / Trial / NCT00648531

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

NCT00648531

Phase 1 Completed 80 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

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

Timeline

Start
2004-05
Primary completion
2004-05
Completion
2004-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Balsalazide Small molecule 2250 mg Oral

Indications

No indication recorded.