%0 Journal Article
%T Bioequivalence of Two Formulations of Metformin Hydrochloride 1000 mg XR Tablets, Fasting Condition in Healthy Adults Subjects
%A Evelyn Pena
%A Alfredo Inatti
%A Anyoly Taly
%A Jos&#233
%A Chac&#243
%A n
%A Xenon Serrano-Martin
%J Journal of Biosciences and Medicines
%P 411-423
%@ 2327-509X
%D 2024
%I Scientific Research Publishing
%R 10.4236/jbm.2024.1212033
%X <b>Background</b>: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. <b>Methods</b>: This was a randomized, single-dose, open-label, two-period, two-sequence, crossover and single-dose study to compare the bioequivalence (BE) profile of Metformin (metformin hydrochloride) 1000 mg XR tablet of Laboratorios Leti S.A.V., with Glucophage&#174; (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters <i>C</i><sub>max</sub>, <math display='inline' xmlns='http://www.w3.org/1998/Math/MathML'>
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 were calculated based on the plasma drug concentration-time profile measured by liquid chromatography-mass spectrometry (LC-MS/MS). The safety was assessed throughout the study. The two formulations test (T) and reference (R) were considered bioequivalent if 90% confidence interval (CI) were within BE acceptance range of 80.00% - 125.00% for <i>C</i><sub>max</sub>, <math display='inline' xmlns='http://www.w3.org/1998/Math/MathML'>
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. <b>Results: </b>A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were <i>C</i><sub>max</sub>: 92.30% (89.08% - 96.97%), <math display='inline' xmlns='http://www.w3.org/1998/Math/MathML'>
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: 91.83% (87.11% - 94.11%) and <math display='inline' xmlns='http://www.w3.org/1998/Math/MathML'>
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: 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted
%K Bioequivalence
%K Metformin
%K Pharmacokinetic
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=138390