TITLE:
Bioequivalence of Two Formulations of Metformin Hydrochloride 1000 mg XR Tablets, Fasting Condition in Healthy Adults Subjects
AUTHORS:
Evelyn Pena, Alfredo Inatti, Anyoly Taly, José Chacón, Xenon Serrano-Martin
KEYWORDS:
Bioequivalence, Metformin, Pharmacokinetic
JOURNAL NAME:
Journal of Biosciences and Medicines,
Vol.12 No.12,
December
24,
2024
ABSTRACT: Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: 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® (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters Cmax,
AUC
0−t
and
AUC
0→∞
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 Cmax,
AUC
0−t
and
AUC
0→∞
. Results: A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were Cmax: 92.30% (89.08% - 96.97%),
AUC
0−t
: 91.83% (87.11% - 94.11%) and
AUC
0→∞
: 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted bioequivalence criteria. The results show that no significant differences were observed between the pharmacokinetic profiles of the T and R formulations. No serious adverse events were reported in this study. Conclusion: The two formulations of metformin hydrochloride 1000 mg XR were bioequivalent in healthy subjects under fasting conditions.