Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly (ME01)

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy Elderly

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02125305

ME01

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Metformin

Experimental group

Description:

Metformin 750mg(D1), Metformin 500mg(D2)

Treatment:

Drug: Metformin