Pharmacokinetics and Relative Bioavailability of Diclofenac Potassium Capsules / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of diclofenac potassium capsules in normal volunteers.METHODS:A single oral 50mg dose of domestic diclofenac potassium capsules or imported diclofenac potassium tablets were given to 10 healthy male volunteers in an open randomized crossover study.Diclofenac potassium concentration in plasma were determined by HPLC.The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS:The concentration－ time curves of domestic diclofenac potassium capsules and imported diclofenac potassium tablets were conformed to one compartment open model.The AUC(0～ 6)was (1 834.52± 711 06） μ g/（ h· L） and (1 891.19± 859.08)μ g/（ h· L） ， Tmax(1.15± 0.77)h and (1.30± 0.97)h,Cmax(1 522.29± 1 063.87)ng/ml and (1 508.54± 892.44)ng/ml respectively.There were no significant differences between the two formulations in the AUC(0～ 6),Tmax,Cmax.CONCLUSION:The relative bioavailability of domestic diclofenac potassium capsule was(100.80± 16 59)％ compared with the imported tablet.The result of the statistical analysis showed that the two formations were bioequivalent.