Relative bioavailability study, randomized, of two pharmaceutical products containing tramadol chlorhydrate 37,5 mg + acetaminophen 325 mg, in healthy volunteers [Estudo de biodisponibilidade relativa, aleatorizado, de dois produtos farmacêuticos contendo cloridrato de tramadol 37,5 mg + paracetamol 325 mg, em voluntários sadios]
De Costa I.O.,Instituto Hermes Pardini Ltda. |
Siqueira A.L.,Federal University of Minas Gerais |
Chellini P.R.,Federal University of Minas Gerais |
De Oliveira P.R.,Federal University of Minas Gerais |
And 3 more authors.
Revista Brasileira de Medicina | Year: 2013
This study aimed to compare the relative bioavailability between two products containing tramadol chlorhydrate + acetaminophen (37,5 mg + 325 mg) film-coated tablets - (test product: Revange®, Aché Laboratórios Farmacêuticos S/A; reference product: Ultracet®, Janssen Cilag Ltda.) in 32 healthy volunteers. The study was open, randomized, cross-over, with two periods in which the volunteers received the test or the reference formulation. The relative bioavailability of the formulations after the drug administration was based on statistics comparisons between pharmacokinetics parameters obtained from blood samples of the volunteers; the samples were taken in a 24 hours period. The concentration of tramadol was measured using an appropriated and valid analytic method. The pharmacokinetics parameters used were: Cmax, AUCt and AUCinf. The range of 90% confidence interval for Cmax was 0.9578 to 1.0702; for AUCt 9396 to 1.0560; and for AUCinf from 0.9399 to 1.0556. The confidence intervals achieved were within the range determined by Brazilian National Health Vigilance Agency (ANVISA) of 80% to 125%, so both products were considered bioequivalent. © Copyright Moreira Jr. Editora.