Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

Study Overview
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Brief Summary
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This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.

Official Title
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A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: DA-1229
* Drug: metformin
* Drug: DA-1229 + metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 to 45, healthy male subjects(at screening) Body weight between 55kg - 90kg, BMI between 18.0 - 27.0 FPG 70-125mg/dL glucose level(at screening) Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. Exclusion Criteria: Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction Subject who already participated in other trials in 2 months Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: D → M → D+M<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |
| Experimental: D → D+M → M<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |
| Experimental: M → D → D+M<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |
| Experimental: M → D+M → D<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |
| Experimental: D+M → M → D<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |
| Experimental: D+M → D → M<br>D : DA-1229 5mg qd, M : metformin 1000mg bid | Drug: DA-1229<br> <br> Drug: metformin<br> <br> Drug: DA-1229 + metformin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss of DA-1229 and metformin |  | up to 168h | 
| Cmax,ss of DA-1229 and metformin |  | up to 168h |