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

May 2, 2018 updated by: Daewoong Pharmaceutical Co. LTD.
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, 6100
        • Pharma Medica Research Inc.

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:

  • 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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ursodiol 500mg tablets
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Drug: Ursodiol 500 MG
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
ACTIVE_COMPARATOR: Urso Forte 500mg tablets
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
Drug: Urso Forte 500Mg Tablet
Urso forte 500mg tablets followed by Ursodiol 500mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: 0-72hours
0-72hours
Area under the plasma concentration versus time curve (AUC)
Time Frame: 0-72hours
0-72hours

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 (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

November 30, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (ACTUAL)

May 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-4053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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