Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

Study Overview
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Brief Summary
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The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

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 LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LC15-0444
* Drug: Metformin
* Drug: LC15-0444+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 or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics) Subject who already participated in other trials in 2months Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently. Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

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: LC15-0444<br>LC15-0444 50mg qd | Drug: LC15-0444<br>* LC15-0444 50mg qd (8 days once daily)<br>|
| Experimental: Metformin<br>Metformin 1000mg bid | Drug: Metformin<br>* Metformin 1000 mg bid (8 days twice daily)<br>|
| Experimental: LC15-0444+Metformin<br>LC15-0444 50mg qd +Metformin 1000mg bid | Drug: LC15-0444+Metformin<br>* LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 | up to 171h30m | 
| Cmax,ss | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 | up to 171h 30m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | to measure Safety and tolerability of the investigational products | up to 171h30m | 
| AUECτ,ss | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity | up to 171h30m | 
| AUEC | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure Active/total GLP-1, glucose, insulin, c-peptide, glucagon. | up to 171h30m |