Bioequivalence and Pharmacokinetic Evaluation Study of Acetaminophen vs. Acetaminophen Plus Caffeine Tablets in Healthy Mexican Volunteers

摘要

ObjectiveThe aim of this clinical trial was to establish the bioequivalence of two tablets containing acetaminophen 650?mg (reference) and acetaminophen 650?mg plus caffeine 65?mg (test), administered orally, in fasting conditions in healthy Mexican volunteers. MethodsBlood samples were taken from 21 male and five female individuals, during a 24-h period, to characterize the pharmacokinetic profile of acetaminophen. Plasma samples were quantified by ultra-performance liquid chromatography, tandem mass spectrometry. Pharmacokinetic metrics (maximum plasma concentration, area under the curve from time zero to the last sampling time, and area under the curve from time zero to infinity) were used to determine the 90?% confidence interval of the test/reference coefficient. ResultsThe geometric mean values for maximum plasma concentration obtained for the reference and test products were 9.46?±?34.21 and 9.72?±?32.38?μg/mL, respectively, whereas for the area under the curve from time zero to the last sampling time the values obtained were 34.93?±?32.58 and 35.89?±?31.03?μg?h/mL for the reference and test formulations, respectively. The 90?% confidence intervals were within the acceptance range (80–125?%). ConclusionsThe test product was bioequivalent to the reference product. A faster absorption was seen in the test formulation in the Mexican population.