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

Phase 1

Completed

• Conditions: Healthy Elderly
• Interventions: Drug: Metformin

• Registration Number: NCT02125305
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Study First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin 750mg(D1), Metformin 500mg(D2)

Primary Outcome Measures

Name	Time	Method
AUC(area under the plasma concentration-time curve)	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose	AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

Secondary Outcome Measures

Name	Time	Method
AUGC(total area under the serum concentration-time curve for glucose concentration)	predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test	AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of