Overview

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