Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

Detailed Description
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The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWJ1458 (fasted)
* Drug: DWJ1458 (fed)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 to 55 years BMI 18.5≥ and ≤27.0 kg/m² Female subjects must be menopause or surgically infertility. Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug. 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: History of hypersensitivity to investigational product Participation in a clinical drug study or bioequivalence study 6 months prior to the present study The subject who is judged to be unsuitable as a test subject in a screening test. The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Group 1<br>Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet. | Drug: DWJ1458 (fasted)<br>* Subjects take single dose of DWJ1458 on a fated condition<br>Drug: DWJ1458 (fed)<br>* Subjects take single dose of DWJ1458 after high-fat diet<br>|
| Experimental: Group 2<br>Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition. | Drug: DWJ1458 (fasted)<br>* Subjects take single dose of DWJ1458 on a fated condition<br>Drug: DWJ1458 (fed)<br>* Subjects take single dose of DWJ1458 after high-fat diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of DWJ1458: AUC0-t | Area under the plasma concentration-time curve from time 0 to time t | 0 - 144 hours after dosing | 
| Pharmacokinetic parameter of DWJ1458: Cmax | Maximum plasma drug concentration | 0 - 144 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of DWJ1458: AUCinf | Area under the plasma concentration-time curve from drug administration to drug elimination | 0 - 144 hours after dosing | 
| Pharmacokinetic parameter of DWJ1458: Tmax | Time to reach maximum plasma concentration following drug administration | 0 - 144 hours after dosing | 
| Pharmacokinetic parameter of DWJ1458: t1/2 | Elimination half-life | 0 - 144 hours after dosing | 
| Pharmacokinetic parameter of DWJ1458: Vd/F | Apparent volume of distribution after oral administration | 0 - 144 hours after dosing | 
| Pharmacokinetic parameter of DWJ1458: Cl/F | Apparent total clearance of drug from plasma after oral administration | 0 - 144 hours after dosing |