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Ursodiol Tablets 500 mg Under Fasting Conditions

NCT00909610 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-19

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Ursodiol

Ursodiol Tablets, 500 mg

DRUG

Urso Forte™

Urso Forte™ Tablets, 500 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Xueyu (Eric) Chen, MD, PhD, FRCP(C) · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909610 on ClinicalTrials.gov