NCT00909610

Ursodiol Tablets 500 mg Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (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 fasting 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: 2006-12-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2009-05-28
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

1 site across 1 country: Canada