Pharmacokinetics and Bioequivalence of Flucloxacillin Capsules in Chinese Healthy Subjects

RUN Zou-rong;ZHOU Qun;YUN Hong;JING o;XU Dong-hng;LOU Hong-gng

Chinese Pharmaceutical Journal ›› 2008, Vol. 43 ›› Issue (09) : 699-701.

Chinese Pharmaceutical Journal ›› 2008, Vol. 43 ›› Issue (09) : 699-701.
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Pharmacokinetics and Bioequivalence of Flucloxacillin Capsules in Chinese Healthy Subjects

  • RUAN Zou-rong,ZHOU Quan,YUAN Hong,JIANG Bo,XU Dong-hang,LOU Hong-gang
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Abstract

OBJECTIVE To study the pharmacokinetics and bioequivalence of flucloxacillin capsules in 20 Chinese healthy subjects.METHODS A single oral dose of 500 mg test or reference of flucloxacillin sodium capsules was given to each subject according to an open randomized crossover design.The concentrations of flucloxacillin in plasma were determined by HPLC method.The pharmacokinetic parameters were calculated and the bioequivalence was evaluated.RESULTS The concentration-time curves of flucloxacillin were fitted into a two-compartment model.The pharmacokinetic parameters of test and reference of flucloxacillin sodium capsules were as follows:tlag(0.1±0.2)and(0.2±0.1)h,tmax(0.8±0.2)and(0.9±0.3)h,ρmax(34.83±7.90)and(30.53 ±10.73)mg·L-1,Ka(4.869±2.135)and(3.682±1.681)h-1,t1/2(1.51±0.39)and(1.45±0.36)h,CL/F(9.268±2.165)and(9.876±2.657)L·h-1,Vd/F(23.58±11.26)and(22.34±12.35)L,AUC0-8 h(69.05±13.26)and(62.22±15.51)mg·h·L-1,AUC0-∞(70.55±13.47)and(63.69±15.69)mg·h·L-1.The relative bioavailability of the test formulation was(114.9±25.1)%.CONCLUSION The flucloxacillin sodium capsules had a rapid absorption and elimination profile in Chinese volunteers.The two flucloxacillin formulations were bioequivalent.

Key words

flucloxacillin / HPLC / pharmacokinetics

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RUN Zou-rong;ZHOU Qun;YUN Hong;JING o;XU Dong-hng;LOU Hong-gng. Pharmacokinetics and Bioequivalence of Flucloxacillin Capsules in Chinese Healthy Subjects [J]. Chinese Pharmaceutical Journal, 2008, 43(09): 699-701

References

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