Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Two doses of metformin with 12 hour interval

* low dose group (375/250 mg) * high dose group (1000/1000mg)

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Primary outcomes

Maximum plasma concentration

Time frame: 0-12 hour
Area under the metformin concentration curve

Time frame: 0-12 hour
Area under the glucose curve

Time frame: 2-5 hour

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers

Important dates

Study start: 2014
Primary completion: 2014
First posted: Mar 18, 2016
Registry last updated: Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed