Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
- Registration Number
- NCT01443221
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Free combination mitiglinide and metformin Free combination of Mitiglinide 10mg and Metformin 500mg Fixed-dose combination mitiglinide and metformin Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of