Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers

An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers

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(DWC202003, DWC202004) in healthy adults.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: DWJ1439; Drug: DWJ1464; Drug: DWC202003; Drug: DWC202004

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(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyung Hee University Medical Hospital
    • Contact: Bo-Hyung Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 alcohol, caffeine, or other xanthines, 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
Other: Sequence A; 7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.	Drug: DWJ1439; 300mg single dose; Drug: DWJ1464; 300mg single dose; Drug: DWC202003; 300mg single dose
Other: Sequence B; 7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.	Drug: DWJ1464; 300mg single dose; Drug: DWC202003; 300mg single dose; Drug: DWC202004; 300mg single dose
Other: Sequence C; 7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.	Drug: DWJ1439; 300mg single dose; Drug: DWC202003; 300mg single dose; Drug: DWC202004; 300mg single dose
Other: Sequence D; 7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.	Drug: DWJ1439; 300mg single dose; Drug: DWJ1464; 300mg single dose; Drug: DWC202004; 300mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t	Area under the plasma concentration-time curve from time 0 to time t	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax	Maximum plasma drug concentration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t	Area under the plasma concentration-time curve from time 0 to time t	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax	Maximum plasma drug concentration	0 - 72 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf	Area under the plasma concentration-time curve from drug administration to drug elimination	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2	Elimination half-life	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F	Apparent total clearance of drug from plasma after oral administration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F	Apparent volume of distribution after oral administration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf	Area under the plasma concentration-time curve from drug administration to drug elimination	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2	Elimination half-life	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F	Apparent total clearance of drug from plasma after oral administration	0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F	Apparent volume of distribution after oral administration	0 - 72 hours after dosing

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 6, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1464101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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