Comparative Bioavailability Study of UDCA

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Ursodeoxycholic Acid

Criteria

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