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Completed

NCT Number: NCT05832697

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.

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Key information

Conditions

Healthy Subject

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyung Hee University Medical Hospital

Seoul, Korea, Republic of, 02447, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ursodeoxycholic Acid 250 Mg Oral Tablet

Drug

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

Other names: Ursodeoxycholic Acid 100 Mg Oral Tablet

Primary outcomes

  1. Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t

    Time frame: -48 - 72hours

    Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t

  2. Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax

    Time frame: -48 - 72hours

    Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax

  3. Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t

    Time frame: -48 - 72hours

    Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t

  4. Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax

    Time frame: -48 - 72hours

    Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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