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

NCT03512821 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-05-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Ursodiol 500 MG

Ursodiol 500mg tablets followed by Urso Forte 500mg tablets

DRUG

Urso Forte 500Mg Tablet

Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512821 on ClinicalTrials.gov