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NCT03512821 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03512821
Other study ID # 2016-4053
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2017
Est. completion date November 30, 2017

Study information
Verified date May 2018
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ursodiol 500 MG
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
• Urso Forte 500Mg Tablet
Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Locations
Country Name City State
Canada Pharma medica research Inc. Mississauga Ontario

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Plasma Concentration (Cmax) 0-72hours
Primary Area under the plasma concentration versus time curve (AUC) 0-72hours
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