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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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT05832697
Collaborator
(none)
44
Enrollment
1
Location
4
Arms
12.1
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
4 by 3 cross-over study4 by 3 cross-over study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 27, 2022
Actual Primary Completion Date :
Jan 30, 2023
Actual Study Completion Date :
Jan 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t [-48 - 72hours]

      Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t

    2. Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax [-48 - 72hours]

      Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax

    3. Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t [-48 - 72hours]

      Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t

    4. Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax [-48 - 72hours]

      Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyung Hee University Medical Hospital Seoul Korea, Republic Of Korea, Democratic People's Republic of 02447

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    • Principal Investigator: BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD, Kyung Hee University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT05832697
    Other Study ID Numbers:
    • DW_DWJ1464103
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ursodeoxycholic Acid

    Study Results

    No Results Posted as of Apr 27, 2023