Estudo de biodisponibilidade comparativa entre duas formulações de cloridrato de metformina comprimidos revestidos de 850 mg, administradas a voluntários sadios

• Autor(a) principal: Rodrigues Neto, Edilson Martins
• Data de Publicação: 2015
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Institucional da Universidade Federal do Ceará (UFC)
• Texto Completo: http://www.repositorio.ufc.br/handle/riufc/11329
• topic: Equivalência Terapêutica; Disponibilidade Biológica

Type 2 diabetes mellitus (DM2 is a syndrome which may be defined as a condition of heterogeneous metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion and action, or both. Metformin is the drug of choice for the treatment of type 2 diabetes, and it is the oral antihyperglyciemic most widely prescribed, due to their favorable toxicity profile and efficacy. Bioavailability studies have several functions including assessment of drugs bioequivalence, evaluation of drugs with new active principles and evaluating new formulations. This study aimed to assess the bioavailability of a formulation of metformin hydrochloride 850 mg film coated tablets, called test formulation, versus a reference formulation in the national market with the same dose of the drug in healthy volunteers of both genders. This is a clinical trial open-type, randomized, crossed, two-period, two-sequence, in which the volunteers received in each distinct period of 01 film coated tablet formulation of 01 test or reference formulation. The formulations were administered in a single oral dose, followed by blood sampling, at least four half-lives of study drug. The treatment periods obeyed an interval of seven half-lives, between them (washout). The metformin plasma concentrations were measured by a specific and validated analytical method based on high efficiency liquid chromatography coupled to mass spectrometry (HELC / MS). The data from this study reveal that the test formulation and the reference formulation showed similar results within the variation limits provided in the regulator norms (80-125%) for AUCinf (area under the curve) and Cmax (maximum serum concentration of drug). Thus, it will be possible ensure interchangeability between the formulations, which could lead to market competition and therefore more competitive prices and easy access to the drug.