Pharmacokinetics and Safety Following Administration of DWP16001

Study Overview
=================
Brief Summary
-----------------
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

Official Title
-----------------
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DWP16001 drug A
* Drug: DWP16001 drug B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years at screening Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening. Exclusion Criteria: Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug Clinical laboratory test values are outside the accepted normal range at screening Other exclusive inclusion criteria, as defined in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence group A<br>DWP16001 A mg 1T | Drug: DWP16001 drug A<br>* 1 tablet, Oral, once daily single dose<br>Drug: DWP16001 drug B<br>* 3 tablet, Oral, once daily single dose<br>|
| Experimental: Sequence group B<br>DWP16001 B mg 3T | Drug: DWP16001 drug A<br>* 1 tablet, Oral, once daily single dose<br>Drug: DWP16001 drug B<br>* 3 tablet, Oral, once daily single dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0_t of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours | 
| Cmax of DWP16001 | Peak Plasma Concetration | 0-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax Tmax | Time at Cmax Tmax | 0-72 hours | 
| AUC of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours | 
| T 1/2 of DWP16001 | half life of DWP16001 | 0-72 hours | 
| CL/F of DWP16001 | Apparent total clearance of the drug from plasma after oral administration | 0-72 hours | 
| Vd/F of DWP16001 | Volume of distribution | 0-72 hours |