Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly

Seoul National University Hospital12 enrolled

Overview

This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Elderly

Interventions

MetforminDRUG

Eligibility

Sex: MALEMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2 * Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis Exclusion Criteria: * If they had clinically relevant disorders * Past history of diabetes or clinical findings to suspect diabetes * Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose \> 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT \> 3 × upper limit of normal)

Locations (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUC(area under the plasma concentration-time curve)

AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary Outcomes

AUGC(total area under the serum concentration-time curve for glucose concentration)

AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Time frame: predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test

Data from ClinicalTrials.gov

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