An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

Healthy Subject Clinical Trial

Official title:

An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832697
• Other study ID #: DW_DWJ1464103
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Subject

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