Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults

Study Overview
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Brief Summary
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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 , DWC202204 and DWC202205 alone or in combination in healthy male adults.

Detailed Description
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* Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule. After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.

Official Title
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A Phase I Clinical Trial to Evaluate the Safety and Drug Interactions Between DWP16001 and in Combination With DWC202204 and DWC202205 in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP16001
* Drug: DWC202204+DWC202205
* Drug: DWP16001+DWC202204+DWC202205


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male adults ≥ 19 years of age at the time of the screening procedure 18.5 ≤ 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
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Minimum Age: 19 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br> | Drug: DWP16001<br>* Tablets, Oral, multiple doses of DWP16001<br>|
| Experimental: Experimental 2<br> | Drug: DWC202204+DWC202205<br>* Tablets, Oral, multiple doses of DWC202204 and DWC202205 in combination<br>|
| Experimental: Experimental 3<br> | Drug: DWP16001+DWC202204+DWC202205<br>* Tablets, Oral, DWP16001 , multiple doses of DWC202204 and DWC202205 in combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of DWP16001 | Peak Plasma Concetration at steady-state | [Time Frame: 0-72 hours] | 
| AUCtau,ss of DWP16001 | Area under the plasma concentration versus time curve at Tau, steady-state | [Time Frame: 0-72 hours] | 
| Cmax,ss of DWC202204 and DWC202205 | Peak Plasma Concetration at steady-state | [Time Frame: 0-24 hours] | 
| AUCtau,ss of DWC202204 and DWC202205 | Area under the plasma concentration versus time curve at Tau, steady-state | [Time Frame: 0-24 hours] |