CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
Ursodiol +1 moredrug
Likely dose
Ursodiol 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00909610
NCT00909610Phase 1Completed
CompareCT.gov

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

Teva Pharmaceuticals USA·interventional·Posted May 28, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Ursodiol and Urso Forte™ for Healthy. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2009
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago

Interventions

Ursodioldrug

Ursodiol Tablets, 500 mg

Urso Forte™drug

Urso Forte™ Tablets, 500 mg