J Med Assoc Thai 1999; 82 (11):1149

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Comparative Bioavailability of Paracetamol
Kaojarern S Mail, Sriapa C , Sirivarasai J , Tongpoo A , Thareerach M

Prescribing 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 pharmacokinetic
analysis there were no statistically significant differences between Tl/2 absorption
and Cmax. Although AUC of Sara was marginally statistically greater than Tylenol, this magnitude
of difference probably has no clinical significance. All these parameters are within the
accepted 20 per cent difference, indicating these products are bioequivalent.
Key word : Bioavailability, Paracetamol

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