Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.

Official Title
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A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP16001
* Drug: Metformin IR
* Drug: DWP16001+Metformin IR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male adults aged 19 to 50 years at the time of screening test 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0 Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc. 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 Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) 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
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: 1<br> | Drug: DWP16001<br>* Tablets, Oral, once daily single dose<br>|
| Experimental: 2<br> | Drug: Metformin IR<br>* Metformin IR 1000mg, Tablets, Oral, BID for 7 days<br>|
| Experimental: 3<br> | Drug: DWP16001+Metformin IR<br>* Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg<br>|

What is the study measuring?
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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 Metformin | Peak Plasma Concetration at steady-state | 0-144 hours | 
| AUCτ,ss of Metformin | Area under the plasma concentration versus time curve at Tau, steady-state | 0-144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of DWP 16001, Metformin, DWP16001 Metabolites | Time at Cmax | 0-144 hours | 
| AUC of DWP 16001, Metformin, DWP16001 Metabolites | Area under the plasma concentration versus time curve | 0-144 hours | 
| T1/2 of DWP 16001, Metformin |  | 0-144 hours | 
| CL/F of DWP 16001, Metformin | Apparent total clearance of the drug from plasma after oral administration | 0-144 hours | 
| fe of DWP 16001, DWP16001 Metabolites | Fraction of the drug excreted into the urine | 0-72 hours | 
| CLR of DWP 16001 | Renal clearance of the drug from plasma | 0-144 hours |