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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05832697
Other study ID # DW_DWJ1464103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 27, 2022
Est. completion date January 30, 2023

Study information

Verified date April 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ursodeoxycholic Acid 250 Mg Oral Tablet
Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet

Locations

Country Name City State
Korea, Democratic People's Republic of Kyung Hee University Medical Hospital Seoul Korea, Republic Of

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Democratic People's Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t Baseline corrected/uncorrected ursodeoxycholic acid? AUC0-t -48 - 72hours
Primary Baseline corrected/uncorrected ursodeoxycholic acid? Cmax Baseline corrected/uncorrected ursodeoxycholic acid? Cmax -48 - 72hours
Primary Baseline corrected/uncorrected total ursodeoxycholic acid? AUC0-t Baseline corrected/uncorrected total ursodeoxycholic acid? AUC0-t -48 - 72hours
Primary Baseline corrected/uncorrected total ursodeoxycholic acid? Cmax Baseline corrected/uncorrected total ursodeoxycholic acid? Cmax -48 - 72hours
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