Comparative Bioavailability Study of UDCA | NCT02385032 | Trialant
CompletedInterventionalPhase 1Updated May 7, 2015
Comparative Bioavailability Study of UDCA
ClinicalTrials.gov ID
NCT02385032
Lead Sponsor
Daewoong Pharmaceutical Co. LTD.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
50Actual
Last Update Posted
May 7, 2015Estimated
Start Date
Feb 2015
Primary Completion Date
Mar 2015Actual
Completion Date
May 2015Actual
Brief Summary
The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.
Healthy
Ursodiol
URSO Forte
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility 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