This study was carried out in order to compare the relative bioavailability of two different formulations containing 400 mg of acetaminophen + 4 mg of phenylephrine hydrochloride + 4 mg of chlorpheniramine maleate, Test formulation (Cimegripe ®) and Reference formulation (Resfenol ®) in 84 healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 3-way and partially replicated. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical methods using the ultra-performance liquid chromatography coupled to tandem mass spectrometry. The C max , T max , AUC 0-t , AUC 0-inf , T 1/2 and Kel pharmacokinetic parameters were calculated from these obtained concentrations. The 90% confidence intervals were constructed for the ratio reference/test from the geometric average of the C max and AUC parameters which were comprised between 80% and 125%. Only the C max parameter of the phenylephrine was applied the scaled average bioequivalence due to the intraindividual coefficient of variation > 30% obtained, thus extending the acceptance limits of the interval. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable.
Study of bioequivalence between two formulations containing dipyrone 300 mg + isometheptene mucate 30 mg + caffeine 30 mg: a randomized, open-lable, two period crossover study in healthy adult Brazilian volunteers Bioequivalência entre duas formulações contendo 300 mg de dipirona + 30 mg de mucato de isometepteno + cafeína 30 mg: um estudo cruzado randomizado, aberto e de dois períodos, em voluntários brasileiros adultos saudáveis
na Publicação (CIP) (eDOC BRASIL, Belo Horizonte/MG) S518 Sexualidade e relações de gênero [recurso eletrônico] / Organizadora Denise Pereira. -Ponta Grossa (PR): Atena Editora, 2019. -(Sexualidade e Relações de Gênero; v. 1)
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.