A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
- Registration Number
- NCT03512821
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Urso Forte 500mg tablets Urso Forte 500Mg Tablet Urso forte 500mg tablets followed by Ursodiol 500mg tablets Ursodiol 500mg tablets Ursodiol 500 MG Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 0-72hours Maximum Plasma Concentration (Cmax) 0-72hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pharma medica research Inc.
🇨🇦Mississauga, Ontario, Canada