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

JW Pharmaceutical24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

mitiglinide and metforminDRUG

Free combination of Mitiglinide 10mg and Metformin 500mg

mitiglinide and metforminDRUG

Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers

Time frame: Up to 36 hours postdose for each period

Secondary Outcomes

Compare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers

Time frame: Up to 36hours postdose for each period

Data from ClinicalTrials.gov

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