Healthy Subject
Conditions
Brief summary
This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
Detailed description
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202108, DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
Interventions
DRUGUrsodeoxycholic Acid 250 Mg Oral Tablet
Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4 by 3 cross-over study
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers aged 19 years old to under 55. * BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg * Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination. * Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG). * Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Exclusion criteria
* Known history or presence of any clinically significant medical condition. Participation in a clinical drug study or bioequivalence study 6 months prior to the present study. * Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period. * Refusal to abstain from caffeine or grapefruit containing food or drinks for 72 hours before drug administration and during each study period. * Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t | -48 - 72hours | Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t |
| Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax | -48 - 72hours | Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax |
| Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t | -48 - 72hours | Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t |
| Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax | -48 - 72hours | Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax |
Countries
South Korea
Outcome results
None listed