Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Seoul National University Hospital20 enrolled

Overview

Two doses of metformin with 12 hour interval * low dose group (375/250 mg) * high dose group (1000/1000mg)

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MetforminDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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