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Comparative Bioavailability Of Two Marketed Tenoxicam Formulations In Healthy Human Volunteers

Author(s): Ramesh Raju, B. G Nagavi, P. K Kulkarni

The objective of the study was to obtain the pharmacokinetic data of two marketed tablet formulations of tenoxicam and compare the relative bioavailability of the test formulation with standard formulation. A single dose 12x2 complete cross over study of the two marketed film coated tablet formulations of tenoxicam (20 mg) was carried out in twelve healthy male volunteers. Blood samples were collected at predetermined time intervals. The plasma concentrations of the drug were determined by RP HPLC. The plasma concentration of the tenoxicam and other pharmacokinetic parameters obtained were statistically analysed. The results of two way analysis of variance of plasma drug levels and pharmacokinetic parameters showed that there was no significant variation between the products and subjects at all the points of time. Products did not show significant difference between them with regard to the AUC0-72, AUC0.75, Cmax, Tmax, T½ which are 153.53±54.54 µg h/ml, 278.92±78.98 µg h/ml, 4.45 µg/ml, 1.66±0.46 h, 65.59±28.19 h respectively for the product A and 157.25±55.02 µg h/ml, 283.84±85.03 µg h/ml, 4.80±1.13 µg/ml 2.04±0.96 h, 62.60±34.53 h for product B. It was therefore, concluded that the products A and B are bioequivalent.


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