Bioavailability study of a new diclofenac slow release tabletin 12 healthy volunteers
Gao Lian · Zhongguo linchuang yaolixue yu zhiliaoxue · 1998
Aim The comparative bioavailability of two diclofenac slow release tablets was studied after a single and repeated oral administration in 12 healthy male volunteers. Methods HPLC method with UV detection was used to determine the serum drug concentrations. Results The pharmacokinetic parameters obtained after single oral administration of the two formulations to the subjects in cross_over design showed that there was not significant difference between the two formulations in maximum concentration(Cmax) and the area under the time_concentration curve (AUC) (P0.05), whereas the time to reach the Cmax of the test tablets (TT) was shorter than that of the reference tablets (RT),with a significant difference between them. The relative bioavailability of TT was 98.11%. The result of the study on the repeated oral doses in 12 subjects indicated that there was no significant difference between the two tablets in Cmax, Cmin,Cave, r and DF (P0.05). The duration of the minimum effective therapeutic drug level (Tmec) and the serum drug concentration peak_trough fluctuation of TT and RT in steady state were similar. Both TT and RT possessed good sustained release property. Conclution The two slow release tablets are bioequivalent formulation, with small difference between the two tablets in Cmax and Cmin. Tpeak of TT in both single and repeated oral doses is significantly shorter than that of RT.