Bioequivalence Study Between Two Formulations of Tramadol Hydrochloride and Acetaminophen Coated Tablets in Healthy Male and Female Subjects Under Fasting Conditions
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: Objective:To evaluate bioequivalence between a new formulation of Tramadol Hydrochloride/Acetaminophen and Ultracet® coated tablets in healthy subjects under fasting conditions. Methods:The present study was conducted as an open-label, monocentric, randomized, 2 x 2 crossover study on 40 healthy subjects in a state of fasting. The objective of the study was to compare the pharmacokinetic profiles of two formulations of tramadol hydrochloride and acetaminophen-coated tablets. The concentrations of the analytes in human plasma were measured using a validated UPLC-MS/MS method. Results:The geometric mean of the test/reference ratio, confidence intervals, and power of the test for the pharmacokinetic parametersCmax and AUC0-t, were determined by statistical analysis, in accordance with the Anvisas guidelines. The geometric mean ratio (90% CI) of the test drug/reference drug for acetaminophen was found to be 82.69% to 100.00% for Cmax and 95.36% to 100.34% for AUC0-t. The results for tramadol hydrochloride were 89.01% to 99.25% for Cmax and 94.86% to 100.71% for AUC0-t. The power of the test was greater than 98%. Conclusion:Both formulations demonstrated bioequivalent profiles, indicating that they are interchangeable in accordance with the Brazilian criteria. This is evidenced by the fact that the confidence intervals for Cmax and AUC0-t ratios were within 80% and 125%, respectively, as stipulated in Anvisa resolution RE nº 1170/2006.
Authors: ATCGen, Campinas, Sao Paulo, Brasil., Carlos Sverdloff, Vinicius Marcondes Rezende, ATCGen, Campinas, Sao Paulo, Brasil., Lygia Nerath Bonanato, Eurofarma Laboratorios S.A., Itapevi, Sao Paulo, Brasil., Camila Kaori Aihara, Eurofarma Laboratorios S.A., Itapevi, Sao Paulo, Brasil., Ana Carolina Costa Sampaio Mendes Cacula, Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas, Aparecida de Goiania, Goiania, Brasil., Karini Bruno Bellorio, Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas, Aparecida de Goiania, Goiania, Brasil.
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: hybrid
OpenAlex ID: W4401400290