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

This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Democratic People's Republic of
  • Korea, Republic Of
    • Seoul, Korea, Republic Of, Korea, Democratic People's Republic of, 02447
      • Kyung Hee University Medical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment A; P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg	Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet; Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet; Other Names: Ursodeoxycholic Acid 100 Mg Oral Tablet
Active Comparator: Treatment B; P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg	Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet; Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet; Other Names: Ursodeoxycholic Acid 100 Mg Oral Tablet
Active Comparator: Treatment C; P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg	Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet; Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet; Other Names: Ursodeoxycholic Acid 100 Mg Oral Tablet
Active Comparator: Treatment D; P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg	Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet; Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet; Other Names: Ursodeoxycholic Acid 100 Mg Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t	Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t	-48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax	Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax	-48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t	Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t	-48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax	Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax	-48 - 72hours

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD, Kyung Hee University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: DW_DWJ1464103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No