Healthy Elderly
Conditions
Keywords
Metformin, Pharmacokinetics/ Pharmacodynamics
Brief summary
This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.
Interventions
DRUGMetformin
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
65 Years to 85 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed