Comparison of Bioavailability and Pharmacokinetic of Two Formulations of Metformin 850 mg Tablets in Healthy Albanian Volunteers

Aim: The aim concerning this study search out equate the bioavailability and pharmacokinetics of two formulations of metformin 850 mg tablets: GLUCOPHAGE® from Merck Santè workshops (citation amount) and METFORMINE from Profarma (test device) in athletic Albanian suggests.Methods: An open label, randomized, two-ending, two-habit crossover study was acted in twenty healthful steps forward for a alone 850 mg quantity of metformin tablets. Pharmacokinetic limits to a degree maximum red body fluid aggregation (Cmax), the extent under the curve restricted to a particular period (AUC0-14h), the extent under the curve to limitless occasion (AUC0-∞), and moment of truth to reach the maximum red body fluid aggregation (Tmax) were driven. The formulations were deliberate bioequivalent if the mathematical mean percentages of ln-mutated Cmax and AUC0-∞ principles were inside the sameness range of 80%-125%.Results: Two Way ANOVA study of the ln-altered Cmax and AUC0-∞ registered that nobody of the belongings checked (expression, ending, inside and middle from two points-subject variances and resume) was statistically important. The bioequivalence study results presented 90% assurance of pauses (90 % CI) for pharmacokinetic limits like Cmax (91.8-115.6 %); AUC0-14 (90.4-109.2 %) AUC0-∞ (90.1-109.1%) and that were inside the range of 0.80-1.25. A p profit of inferior 0.05 was thought-out statistically meaningful.Conclusion: The device METFORMINE (caused by Profarma Sh.a) is bioequivalent and, accordingly, completely transposable concerning AUC0-∞ and Cmax when distinguished accompanying the remark crop (GLUCOPHAGE®).

Author(s) Details:

Eva Troja,
University of Medicine, Albania.

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Keywords: Metformin, bioequivalence, bioavailability, pharmacokinetics, interchange of drugs, area under curve

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