NCT00648531

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

Single-Dose Fasting In Vivo Bioequivalence Study of Balsalazide Disodium Capsules (750 mg; Mylan) and Colazal® Capsules (750 mg; Salix) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Balsalazide Disodium Capsules 750 mg	3x750mg, single dose fasting
DRUG	Colazal® Capsules 750 mg	3x750mg, single dose fasting

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States