Comparative Bioavailability Study of UDCA

May 5, 2015 updated by: Daewoong Pharmaceutical Co. LTD.
The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AB
Ursodiol followed by URSO Forte
Drug: Ursodiol
Drug: URSO Forte
EXPERIMENTAL: BA
URSO Forte followed by Ursodiol
Drug: Ursodiol
Drug: URSO Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 72 hours
72 hours
Cmax
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (ESTIMATE)

March 11, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_UDCA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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