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.

Lead exposure and accumulation in healthy Thais: assessed by lead levels, EDTA mobilization and heme synthesis-related parameters.

Lead is one of the pollutants which is of public concern. The magnitude of lead contamination in Thai people is of interest. The objective of this study was to evaluate the lead status in normal healthy volunteers. Normal volunteers were included. The blood for lead level, Zinc protoporphyrin (ZPP), delta-aminolevulinic acid dehydratase (ALA-D) activity, and baseline urine for lead, delta-aminolevulinic acid (ALA) and coproporphyrinogen III (CP3) were collected. The EDTA mobilization test was done. 24 hour urine after administration of the drug was collected for lead analysis. Thirty volunteers were included in the study. All were men whose average age was 32.5 +/- 6.9 years. The mean lead level was 5.95 +/- 2.01 micrograms/dL and 5.83 +/- 2.32 micrograms/L in urine. The 24 hour urine lead contents before and after EDTA administration were significantly different (11.11 +/- 6.72 and 16.05 +/- 9.51 micrograms respectively). Blood ALA-D activity was 251.6 +/- 80.4 unit/ml of RBC. Urine ALA and CP3 were 0.56 +/- 1.2 mg/L and 22.17 +/- 23.9 micrograms/L respectively. All were in the normal ranges. All parameters suggested that the healthy Thai volunteers had an acceptable magnitude of lead exposure and accumulation.