Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

Study Overview
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Brief Summary
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To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Detailed Description
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The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.

Official Title
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Open-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: mitiglinide and metformin
* Drug: mitiglinide and metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.) Subject with normal results in blood pressure, pulse, body temperature and ECG test Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2 Exclusion Criteria: Clinically significant functional disorder or acute disease Chronic disease affecting the absorption, metabolism or excretion of drug Any study drug administration within 90 days before the first drug administration Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free combination<br>Free combination of Mitiglinide 10mg and Metformin 500mg | Drug: mitiglinide and metformin<br>* Free combination of Mitiglinide 10mg and Metformin 500mg<br>|
| Experimental: Fixed-dose combination<br>Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg | Drug: mitiglinide and metformin<br>* Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers |  | Up to 36 hours postdose for each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers |  | Up to 36hours postdose for each period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitiglinide, metformin, Pharmacokinetics, Safety