Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon® & Glucophage®) – in healthy human volunteers

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Abstract
A randomized, two‐way, crossover study was conducted in 24 fasting, healthy, male volunteers to compare the bioavailability of two brands of metformin 500 mg tablets; Dialon® (Julphar, UAE) as test and Glucophage® (Lipha Pharmaceutical Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Al‐Mowasah Hospital, Amman, Jordan. The drug was administered with 240 ml of water after a 10‐h overnight fasting on two treatment days separated by 1‐week washout period. After dosing, serial blood samples were collected for a period of 30 h. Plasma harvested from blood was analyzed for metformin by validated HPLC method with UV‐visible detector capable to detect metformin in the range of 0.05–5.0 μg/ml with limit of quantitation of 0.05 μg/ml. Various pharmacokinetic parameters including AUC0−t, AUC0−∝, Cmax, Tmax, T1/2, and λZ were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. AUC0−t, AUC0−∝ and Cmax were tested for bioequivalence after log‐transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (97.9–110.8% for AUC0−t, 97.4–110.7% for AUC0−∝; 95.3–110.5% for Cmax) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80–125%. Based on these statistical inferences, it was concluded that Dialon® is bioequivalent to Glucophage®. Copyright © 2002 John Wiley & Sons, Ltd.