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

NCT05832697 | Completed Phase 1

• 1 other identifier: DW_DWJ1464103
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Treatment A

ACTIVE COMPARATOR

P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg

Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet

Treatment B

ACTIVE COMPARATOR

P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg

Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet

Treatment C

ACTIVE COMPARATOR

P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg

Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet

Treatment D

ACTIVE COMPARATOR

P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg

Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet

Interventions

Ursodeoxycholic Acid 250 Mg Oral Tablet DRUG

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

Also known as: Ursodeoxycholic Acid 100 Mg Oral Tablet

Treatment A; Treatment B; Treatment C; Treatment D

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Kyung Hee University Medical Hospital

Seoul, Korea, Republic of, 02447, South Korea

Location

MeSH Terms

Interventions

Ursodeoxycholic Acid; Tablets

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Dosage Forms; Pharmaceutical Preparations

Study Officials

• BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 by 3 cross-over study

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 27, 2023
• Study Start: January 27, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

KR (1)