A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

Summary

single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

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

Details

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

Criteria

Inclusion Criteria:

• Healthy, non-smoking, male and female subjects, 18 years of age or older

• BMI ≥ 19.0 and ≤ 30.0 kg/m2.

• Females who participate in this study will be of chilbearing or nonchildbearing potential

Exclusion Criteria:

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results