Status:
COMPLETED
Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Lead Sponsor:
JW Pharmaceutical
Conditions:
Healthy
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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 mal...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01443221
Start Date
December 1 2010
End Date
January 1 2011
Last Update
September 29 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea