Comparative Bioavailability Study of UDCA

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ursodiol; Drug: URSO Forte

• Registration Number: NCT02385032
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-11
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• BMI ≥ 19.0 and ≤ 30.0 kg/m2.
• No clinically significant findings in a 12-lead electrocardiogram (ECG)
• Be informed of the nature of the study and give written consent prior to any study procedure

Exclusion Criteria

• Known history or presence of any clinically significant medical condition
• Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BA	URSO Forte	URSO Forte followed by Ursodiol
AB	URSO Forte	Ursodiol followed by URSO Forte
AB	Ursodiol	Ursodiol followed by URSO Forte
BA	Ursodiol	URSO Forte followed by Ursodiol

Primary Outcome Measures

Name	Time	Method
Cmax	72 hours
AUClast	72 hours