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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Other Intervention Names

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Diabex

Eligibility Criteria

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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)

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes