Healthy
Conditions
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
Interventions
DRUGUrsodiol 500 MG
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) | 0-72hours |
| Area under the plasma concentration versus time curve (AUC) | 0-72hours |
Countries
Canada
Outcome results
None listed