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Evaluation of the bioequivalence of two formulations containing the combination of 400 mg of acetaminophen (paracetamol), 4 mg of phenylephrine and 4 mg of chlorpheniramine in capsules: open-label, three-way crossover study, partially replicated in healthy volunteers of both sexes
Santos, Alessandra Ferreira dos; Santos, Quevellin Alves dos; Correa, Carlos Eduardo Melo; Coelho, Edvaldo Capobiango.
  • Santos, Alessandra Ferreira dos; Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda. Pouso Alegre. BR
  • Santos, Quevellin Alves dos; Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda. Pouso Alegre. BR
  • Correa, Carlos Eduardo Melo; Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda. Pouso Alegre. BR
  • Coelho, Edvaldo Capobiango; Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda. Pouso Alegre. BR
Braz. J. Pharm. Sci. (Online) ; 56: e17836, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132033
ABSTRACT
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 Cmax, Tmax, AUC0-t, AUC0-inf, T1/2 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 Cmax and AUC parameters which were comprised between 80% and 125%. Only the Cmax 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
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Phenylephrine / Capsules / Biological Availability / Chlorpheniramine / Acetaminophen Type of study: Controlled clinical trial Limits: Female / Humans / Male Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2020 Type: Article Affiliation country: Brazil Institution/Affiliation country: Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda/BR

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Full text: Available Index: LILACS (Americas) Main subject: Phenylephrine / Capsules / Biological Availability / Chlorpheniramine / Acetaminophen Type of study: Controlled clinical trial Limits: Female / Humans / Male Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2020 Type: Article Affiliation country: Brazil Institution/Affiliation country: Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda/BR