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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country44 target enrollmentJanuary 27, 2022

ConditionsHealthy Subject

InterventionsUrsodeoxycholic Acid 250 Mg Oral Tablet

DrugsUrsodeoxycholic Acid 250 Mg Oral Tablet

Overview

Phase: Phase 1
Intervention: Ursodeoxycholic Acid 250 Mg Oral Tablet
Conditions: Healthy Subject
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 44
Locations: 1
Primary Endpoint: Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 27, 2022

End Date

January 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult volunteers aged 19 years old to under
•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.