Aim: The aim concerning this study was to equate the bioavailability and pharmacokinetics of two formulations of metformin 850 mg tablets: GLUCOPHAGE® from Merck Santè laboratories (remark product) and METFORMINE from Profarma (test device) in healthy Albanian volunteers.Methods: An open label, randomized, two-ending, two-way crossover study was acted in twenty healthy signs up for a single 850 mg shot of metformin tablets. Pharmacokinetic parameters in the way that maximum plasma aggregation (Cmax), the area under the curve limited to a particular time (AUC0-14h), the field under the curve to infinite occasion (AUC0-∞), and the time to reach the maximum red body fluid concentration (Tmax) were persistent. The formulations were considered bioequivalent if the mathematical mean ratios of ln-transformed Cmax and AUC0-∞ principles were within the similarity range of 80%-125%.Results: Two Way ANOVA analysis of the ln-converted Cmax and AUC0-∞ indicated that nobody of the effects checked (formulation, ending, within and between-subject variances and continue) was statistically significant. The bioequivalence study results accompanied 90% confidence of breaks (90 % CI) for pharmacokinetic parameters like Cmax (91.8-115.6 %); AUC0-14 (90.4-109.2 %) AUC0-∞ (90.1-109.1%) and that were within the range of 0.80-1.25. A p advantage of less than 0.05 was deliberate statistically significant.Conclusion: The fruit METFORMINE (produced by Profarma Sh.a) is bioequivalent and, therefore, adequately interchangeable concerning AUC0-∞ and Cmax when compared accompanying the reference crop (GLUCOPHAGE®).
Author(s) Details:
Eva Troja,
University
of Medicine, Albania.
Please see the link here: https://stm.bookpi.org/CAPR-V9/article/view/8678
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