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

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.

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