A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet
Authors: Ibáñez, Y.1; Rodríguez, J.M.1; Luján, M.1; Grattan, T.J.2; Martin, A.J.2; Burnett, I.2
Source: Current Medical Research and Opinion, Volume 22, Number 10, October 2006 , pp. 1893-1897(5)
Publisher: Informa Healthcare
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Abstract:
Objective: A rapidly absorbed tablet formulation of paracetamol containing sodium bicarbonate (PS) has been previously shown to be absorbed at least twice as fast as a standard paracetamol tablet (P) at a 1 g dose. In South America and Asia it is customary for patients to take a 500 mg dose of analgesic. The objective of this pharmacokinetic study was to compare the rate of absorption of PS versus P at a 500 mg dose.Research design and methods: An open, randomized, single dose, cross-over study. Thirty Hispanic healthy volunteers randomly received a 500 mg dose taken orally with 50 mL of water 2 h after a standard breakfast. Blood samples were taken up to 10 h post-dose. Plasma concentrations of paracetamol were determined by HPLC with UV detection.Main outcome measures: AUC0-30 min, Cplasma 30 min and Tmax were analyzed non-parametrically by the Wilcoxon's rank sum test. A linear mixed effects model was used to analyze the logarithmically transformed AUC0-∝ and Cmax. Bioequivalence was accepted if the 90% confidence intervals (CI) for the ratio of the means of the primary pharmacokinetic variable AUC0-∝ lay completely within the range 0.80-1.25.Results: AUC0-30 min and Cplasma 30 min were significantly greater and Tmax was significantly shorter (all p < 0.0001) for PS versus P. The formulations were bioequivalent for AUC0-∝ (90% CI 0.99:1.05) and no statistical difference was seen for Cmax (95% CI 0.91:1.14).Conclusions: Paracetamol was absorbed at least twice as fast from PS compared to P at a 500 mg dose. The extent of absorption was equivalent for both formulations.Keywords: PARACETAMOL; PHARMACOKINETIC; RATE OF ABSORPTION; SODIUM BICARBONATE
Document Type: Case report
DOI: 10.1185/030079906X132596
Affiliations: 1: Unidad de Farmacología Clínica, Hospital Español-Facultad de Medicina, Universidad Nacional Autonoma de Mexico, Mexico; Laboratorio de Biofarmacia, Unidad Analitica de Estudios de Bioequivalencia, Facultad de Química, Universidad Nacional Autonoma de Mexico, Mexico 2: GlaxoSmithKline Consumer Healthcare, Weybridge, Surrey, UK
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