A New Rapidly Absorbed Paracetamol Tablet Containing Sodium Bicarbonate. I. A Four-Way Crossover Study to Compare the Concentration–Time Profile of Paracetamol from the New Paracetamol/Sodium Bicarbonate Tablet and a Conventional Paracetamol Tablet in Fed and Fasted Volunteers

Autor:	Mohammad Reza Shiran, Tim J. Grattan, Geoffrey T. Tucker, R. Ayesh, Amin Rostami-Hodjegan, I. Burnett, A. Darby-Dowman
Rok vydání:	2002
Předmět:	Adult Male Adolescent Chemistry Pharmaceutical Analgesic Cmax Administration Oral Pharmaceutical Science Pharmacology Bioequivalence Dosage form Excipients Food-Drug Interactions chemistry.chemical_compound Pharmacokinetics Drug Discovery Humans Medicine Mercapturic acid Acetaminophen Analysis of Variance Cross-Over Studies Sodium bicarbonate Chromatography business.industry digestive oral and skin physiology Organic Chemistry Fasting Analgesics Non-Narcotic Middle Aged Crossover study Sodium Bicarbonate Solubility Therapeutic Equivalency chemistry Area Under Curve business Tablets
Zdroj:	Drug Development and Industrial Pharmacy. 28:523-531
ISSN:	1520-5762 0363-9045
DOI:	10.1081/ddc-120003448
Popis:	The primary objective of this four-way crossover study was to compare the concentration-time profile of paracetamol from a new rapidly absorbed paracetamol tablet containing sodium bicarbonate (PS) with a conventional paracetamol tablet (P), in a panel of 28 fed and fasted healthy volunteers. The results demonstrated that paracetamol was absorbed more rapidly from tablets containing sodium bicarbonate compared to conventional tablets, as indicated by a shorter tmax in both the fed and fasted state and a higher Cmax in the fasted state. The two formulations were bioequivalent with respect to area under curve (AUC). Food did not affect the extent of absorption from either formulation, as indicated by AUC, however, food did reduce the rate of absorption from both formulations, as indicated by a longer tmax and a lower Cmax. Metabolic activation of paracetamol to its oxidation metabolites, as assessed by combined partial clearances to subsequent secondary metabolites cysteine and mercapturic acid conjugates, indicated that the two formulations were bioequivalent in this respect.
Databáze:	OpenAIRE
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