©2002 Marcel Dekker, Inc. All rights reserved. This material may not be used or reproduced in any form without the express written permission of Marcel Dekker, Inc. MARCEL DEKKER, INC. • 270 MADISON AVENUE • NEW YORK, NY 10016 RESEARCH PAPER 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 A. Rostami-Hodjegan, 1 M. R. Shiran, 1 R. Ayesh, 2 T. J. Grattan, 3, * I. Burnett, 3 A. Darby-Dowman, 3 and G. T. Tucker 1 1 The University of Sheffield Section of Medicine and Pharmacology, Royal Hallamshire Hospital, Sheffield, UK 2 BIBRA International, Woodmansterne Road, Carshalton, Surrey, UK 3 GlaxoSmithKline Consumer Healthcare, St Georges Avenue, Weybridge, Surrey, UK ABSTRACT The primary objective of this four-way crossover study was to compare the con- centration–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 demon- strated that paracetamol was absorbed more rapidly from tablets containing sodium bicarbonate compared to conventional tablets, as indicated by a shorter t max in both the fed and fasted state and a higher C max in the fasted state. The two *Corresponding author. Fax: (44)1932822326; E-mail: Tim.J.Grattan@GSK.com Drug Development and Industrial Pharmacy, 28(5), 523–531 (2002) 523 Copyright # 2002 by Marcel Dekker, Inc. www.dekker.com