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

JW Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: mitiglinide and metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01443221

CWP-KAD-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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