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

Healthy Elderly Clinical Trial

— ME01  

Official title:

A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125305
• Other study ID #: ME01
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2014
• Last updated: April 28, 2014
• Start date: August 2013

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Elderly

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(area under the plasma concentration-time curve)	AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose	No
Secondary	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)	predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test	No