Comparative bioavailability of paracetamol.
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 Nakorn 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 T1/2 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.
Kaojarern
S
S
Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Sriapa
C
C
Sirivarasai
J
J
Tongpoo
A
A
Thareerach
M
M
D000082:Acetaminophen / Q000493:pharmacokinetics*; D018712:Analgesics, Non-Narcotic / Q000493:pharmacokinetics*; D001682:Biological Availability; D018592:Cross-Over Studies; D016568:Drugs, Generic; D006801:Humans; D013810:Therapeutic Equivalency
D018712:Analgesics, Non-Narcotic; D016568:Drugs, Generic; D000082:Acetaminophen