Comparative Bioavailability of Paracetamol

SMING KAOJARERN, M.D.*, JINTANA SIRIV ARASAI, M.Sc. *, MALINEE THAREERACH, B.Sc. *, CHARUWAN SRIAPA, M.Sc.*, ACHARA TONGPOO, M.Sc.*,

Affiliation : * Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok I 0400, Thailand.

AbstractPrescribing brand name versus generic drugs continues to be a controversial issue. The harmful effects of nonequivalence result from either too little or too much drug reaching the patient which will cause either failure of treatment or adverse drug reactions. On the other hand, if physicians prescribe higher priced original drugs instead of therapeutically equivalent lower cost generic drugs to their patients, the patients then have to pay for the added cost. This study was designed to compare the bioavailability of paracetamol of a generic versus original drug. The original brand (Tylenol, Cilag) which was assigned as the reference standard against another generic formulation (Sara, Thai Nakom Patana). Ten healthy male volunteers aged 20 to 45 years participated in this study. The study was conducted as a cross-over experimental design. The dose was 2 tablets of 500 mg. In conclusion, based on the concentration-time curve and phar- macokinetic analysis there were no statistically significant differences between Tl/2 absorption and Cmax. Although AUC of Sara was marginally statistically greater than Tylenol, this mag- nitude of difference probably has no clinical significance. All these parameters are within the accepted 20 per cent difference, indicating these products are bioequivalent.

Keywords : Bioavailability, Paracetamol

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