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

Abstract

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.

Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia)

“…As we could not find any information in the literature on the variability of PK parameters in a palliative care population, we relied on the number of subjects included in clinical studies with similar methodologies [4,[9][10][11][12] and decided to include 20 patients. This number is also in line with the recommendations of the European Medicines Agency [13], which sets at 12 the minimum number of patients to be included in a bioequivalence trial.…”

“…3 Caen University Hospital, Pharmacy, 14000 Caen, France. 4 Clinical Research Department, Caen University Hospital, 14000 Caen, France.…”

Bioequivalence Evaluation of Two Oral Formulations of Acetaminophen in Healthy Subjects: Results From a Randomized, Single‐Blind, Crossover Study

“…In Mexico, there are currently more than 50 marketed products that contain acetaminophen, either alone or in combination with other drugs, and in different dosages and formulations . However, despite such widespread availability of acetaminophen in Mexico, data on the pharmacokinetic properties of acetaminophen in Mexican populations are quite limited …”