NCT00909753

Ursodiol 500 mg Tablets Under Fed Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ursodiol	Ursodiol Tablets, 500 mg
DRUG	Urso Forte™	Urso Forte™ Tablets, 500 mg

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2009-05-28
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

1 site across 1 country: Canada