The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.
Twenty-four subjects were given a single dose of 500 mg Metformin film-coated tablet of either formulation (test or reference) with 240 mL of a 20% glucose solution in water.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
Metformin is an antihyperglycemic drug used in the management of type-2 diabetes. Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
PT Pharma Metric Labs
Jakarta Pusat, DKI Jakarta, Indonesia
Geometric Mean Ratio
The ratio between maximum concentration of test drug and reference drug after drug administration
Time frame: 0-24 hours post dose
Geometric Mean Ratio
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
Time frame: 0-24 hours post dose
Pharmacokinetics Parameter
Maximum plasma concentration (Cmax)
Time frame: 0-24 hours post dose
Pharmacokinetics Parameter
Area Under Curve from 0 to 24 hours (AUCt)
Time frame: 0-24 hours post dose
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