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Completed

NCT Number: NCT02125305

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

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

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Key information

Conditions

Healthy Elderly

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

metformin

Drug

Other names: Diabex

Primary outcomes

  1. AUC(area under the plasma concentration-time curve)

    Time frame: 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 outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: ME01

Important dates

Study start
2013
Primary completion
2014
First posted
Apr 29, 2014
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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