Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers
- Registration Number
- NCT02712619
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Two doses of metformin with 12 hour interval
* low dose group (375/250 mg)
* high dose group (1000/1000mg)
- Detailed Description
A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Age 20 to 45
- Body weight 50 to 100 kg
- fasting serum glucose 70 to 125 mg/dL
- who provide informed consent voluntarily
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Exclusion Criteria
- any significant renal, gastrointestinal, hepatic, and metabolic condition
- any co/prior medication within 14 days of study drug administration
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description metformin 250mg Metformin metformin 375/250 mg metformin 1000mg Metformin metformin 1000/1000 mg
- Primary Outcome Measures
Name Time Method Maximum plasma concentration 0-12 hour Area under the metformin concentration curve 0-12 hour Area under the glucose curve 2-5 hour
- Secondary Outcome Measures
Name Time Method