Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.

Official Title
-----------------
A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

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

Intervention / Treatment
-----------------
* Drug: DWP16001
* Drug: DWC202001+DWC202002
* Drug: DWP16001+DWC202001+DWC202002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0 Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc. Exclusion Criteria: Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.) Considered ineligible for the study by the investigator for reasons including laboratory test results

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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: 1<br> | Drug: DWP16001<br>* Tablets, Oral, once daily single dose<br>|
| Experimental: 2<br> | Drug: DWC202001+DWC202002<br>* Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination<br>|
| Experimental: Experimental 3<br> | Drug: DWP16001+DWC202001+DWC202002<br>* Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of DWP16001 | Peak Plasma Concetration | 0-72 hours | 
| AUClast of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours | 
| Cmax,ss of DWC202001 and DWC202002 | Peak Plasma Concetration at steady-state | 0-72 hours | 
| AUCτ,ss of DWC202001 and DWC202002 | Area under the plasma concentration versus time curve at Tau, steady-state | 0-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of DWP 16001, DWC202001 and DWC202002 | Time at Cmax | 0-72 hours | 
| T1/2 of DWP 16001, DWC202001 and DWC202002 |  | 0-72 hours | 
| CL/F of DWC202001 and DWC202002 |  | 0-72 hours |