Bioequivalence study of two metformin formulations.

Area of Science:

• Pharmacokinetics
• Clinical Pharmacology
• Drug Formulation Analysis

Background:

• Metformin is a widely used oral hypoglycemic agent for type 2 diabetes.
• Ensuring therapeutic equivalence between generic and reference drug products is crucial for patient care.
• Bioavailability studies are essential for demonstrating interchangeability of pharmaceutical formulations.

Purpose of the Study:

• To compare the bioavailability of Emiphage (test) metformin formulation against a reference preparation.
• To assess the pharmacokinetic profile and bioequivalence of two 850 mg metformin tablet formulations.
• To determine if Emiphage can be considered therapeutically equivalent to the original metformin formulation.

Main Methods:

• A randomized, single-dose, cross-over study involving 24 healthy male volunteers.
• Administration of an 850 mg dose of each metformin formulation after an overnight fast, with a 7-day washout period.
• Serum metformin concentrations measured using High-Performance Liquid Chromatography (HPLC) with pharmacokinetic parameters analyzed by non-compartmental methods.

Main Results:

• Key pharmacokinetic parameters including C(max), T(max), AUC(0-t), AUC(0-infinity), and t(1/2) were calculated for both formulations.
• Parametric 90% confidence intervals for the ratio of test to reference formulations for AUC(0-t), AUC(0-infinity), and C(max) were within the accepted bioequivalence range.
• No significant differences were observed in the pharmacokinetic profiles between the Emiphage and reference metformin formulations.

Conclusions:

• The Emiphage metformin formulation demonstrates bioequivalence to the reference preparation.
• The two metformin tablet formulations are considered equivalent in the extent of absorption under fasting conditions.
• These findings support the interchangeability of Emiphage with the reference metformin product.