Comparative Bioavailability Study of UDCA

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ursodiol; Drug: URSO Forte

Study type: Interventional

Funder types: Industry

Identifiers

NCT02385032

DW_UDCA001

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

AB

Experimental group

Description:

Ursodiol followed by URSO Forte

Treatment:

Drug: URSO Forte

Drug: Ursodiol

BA

Experimental group

Description:

URSO Forte followed by Ursodiol

Treatment:

Drug: URSO Forte

Drug: Ursodiol