Back to resultsA Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ursodiol 500 MG
Urso Forte 500Mg Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility 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
Sites / Locations
- Pharma medica research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ursodiol 500mg tablets
Urso Forte 500mg tablets
Arm Description
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT03512821
First Posted
April 19, 2018
Last Updated
May 2, 2018
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03512821
Brief Title
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Official Title
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ursodiol 500mg tablets
Arm Type
Experimental
Arm Description
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Arm Title
Urso Forte 500mg tablets
Arm Type
Active Comparator
Arm Description
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
Intervention Type
Drug
Intervention Name(s)
Ursodiol 500 MG
Intervention Description
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Intervention Type
Drug
Intervention Name(s)
Urso Forte 500Mg Tablet
Intervention Description
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Time Frame
0-72hours
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
0-72hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Pharma medica research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
6100
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
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