Healthy
Conditions
Brief summary
The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.
Interventions
DRUGUrsodiol
DRUGURSO Forte
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BMI ≥ 19.0 and ≤ 30.0 kg/m2. * No clinically significant findings in a 12-lead electrocardiogram (ECG) * Be informed of the nature of the study and give written consent prior to any study procedure
Exclusion criteria
* Known history or presence of any clinically significant medical condition * Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast | 72 hours |
| Cmax | 72 hours |
Outcome results
None listed