Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metformin

• 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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-09
• Study First Submitted: 2016-02-22
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-14
• Last Update Submitted: 2016-03-14
• Study First Posted: 2016-03-18
• Last Update Posted: 2016-03-18

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

Exclusion Criteria

• any significant renal, gastrointestinal, hepatic, and metabolic condition
• any co/prior medication within 14 days of study drug administration

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