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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWJ1439
* Drug: DWJ1464
* Drug: DWC202003
* Drug: DWC202004


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence A<br>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<br>* 300mg single dose<br>Drug: DWJ1464<br>* 300mg single dose<br>Drug: DWC202003<br>* 300mg single dose<br>|
| Other: Sequence B<br>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<br>* 300mg single dose<br>Drug: DWC202003<br>* 300mg single dose<br>Drug: DWC202004<br>* 300mg single dose<br>|
| Other: Sequence C<br>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<br>* 300mg single dose<br>Drug: DWC202003<br>* 300mg single dose<br>Drug: DWC202004<br>* 300mg single dose<br>|
| Other: Sequence D<br>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<br>* 300mg single dose<br>Drug: DWJ1464<br>* 300mg single dose<br>Drug: DWC202004<br>* 300mg single dose<br>|

What is the study measuring?
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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 |