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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477369
• Other study ID #: DW_DWJ1464101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 6, 2020
• Est. completion date: September 2020

Study information

• Verified date: July 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Bo-Hyung Kim
• Phone: +82-2-958-9326
• Email: bhkim98[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWJ1439
300mg single dose
• DWJ1464
300mg single dose
• DWC202003
300mg single dose
• DWC202004
300mg single dose

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Medical Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax	Maximum plasma drug concentration	0 - 72 hours after dosing
Primary	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
Primary	PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax	Maximum plasma drug concentration	0 - 72 hours after dosing
Secondary	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
Secondary	PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 72 hours after dosing
Secondary	PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2	Elimination half-life	0 - 72 hours after dosing
Secondary	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
Secondary	PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F	Apparent volume of distribution after oral administration	0 - 72 hours after dosing
Secondary	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
Secondary	PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 72 hours after dosing
Secondary	PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2	Elimination half-life	0 - 72 hours after dosing
Secondary	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
Secondary	PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F	Apparent volume of distribution after oral administration	0 - 72 hours after dosing