Study on the Bioequiavailability of Diclofenac Potassium Capsule in Human Body
Jie Pan, Qiu Yi-qun, Zhengming He
Abstract
Jie Pan, Qiu Yi-qun, Zhengming He
Abstract
OBJECTIVE:To study the bioequiavailability of2kinds of diclofenac potassium capsules in human body.METHODS:The blood concentrations of the20healthy male volunteers were determined by HPLC-MS;the pharmacokinetics and the bioequiavailability in whom were calculated after orally taking by randomized crossover way single dose of trial capsule and reference capsule.RESULT:The concentration-time curves of the trial capsules and the reference capsules were in conformity with one-compartment model.The experiment data showed that the AUC 0~8 of the2kind of capsules were(2.27±0.66)、(2.16±0.58)(μg·h)/ml,respectively;their C max were(1.27±0.40)and(1.38±0.58)μg/ml,respectively;their t max were(0.9±0.7)、(1.0±0.7)h,respectively.The relative bioavailability of the trial capsules was(104.9±12.8)%.CONCLUSION:The2kinds of diclofenac potassium capsules are bioequivalent.
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OBJECTIVE:To study the bioequiavailability of2kinds of diclofenac potassium capsules in human body.METHODS:The blood concentrations of the20healthy male volunteers were determined by HPLC-MS;the pharmacokinetics and the bioequiavailability in whom were calculated after orally taking by randomized crossover way single dose of trial capsule and reference capsule.RESULT:The concentration-time curves of the trial capsules and the reference capsules were in conformity with one-compartment model.The experiment data showed that the AUC 0~8 of the2kind of capsules were(2.27±0.66)、(2.16±0.58)(μg·h)/ml,respectively;their C max were(1.27±0.40)and(1.38±0.58)μg/ml,respectively;their t max were(0.9±0.7)、(1.0±0.7)h,respectively.The relative bioavailability of the trial capsules was(104.9±12.8)%.CONCLUSION:The2kinds of diclofenac potassium capsules are bioequivalent.
Key concepts: Bioequivalence, Capsule, Bioavailability, Pharmacokinetics, Potassium, Diclofenac, Crossover study, Pharmacology