氟康唑胶囊在健康人体的生物等效性研究

Bioequivalence of Fluconazole Capsules in Healthy Volunteers

目的:研究两种氟康唑胶囊的相对生物利用度,并评价两者的生物等效性。方法:采用双周期自身随机交叉试验设计,22名健康男性志愿者单剂量口服试验制剂或参比制剂,血浆样品采用高效液相色谱法测定。结果:受试制剂及参比制剂氟康唑胶囊实测平均血药峰浓度Cmax分别为(7.13±1.34),(6.72±1.13)mg·L-1;实测平均达峰时间tmax分别为(0.84±0.76),(1.04±0.91)h;受试制剂及参比制剂t1/2(ke)分别为(25.93±4.33),(25.93±5.70)h;AUC0-t平均值分别为(212.47±29.54),(208.80±31.56)mg·h·L-1;AUC0-∞平均值分别为(224.74±30.99),(221.79±32.46)mg·h·L-1;试验制剂氟康唑胶囊的相对生物利用度F0-t、F0-∞分别为(102.53±11.04)%,(102.03±10.95)%。结论:试验制剂和参比制剂具有生物等效性。

Objective： To evaluate the bioavailability and bioequivalence between two kinds of fluconazole capsules. Methods： A single oral dose of fluconazole capsules of test and reference preparations were given respectively to 22 healthy male volunteers in a self random two-way cross over design and serum concentration was determined by HPLC. Results： The main pharmacokinetie parameters of test preparation and reference preparation were as follows： Cmax （7.13 ± 1.34）, （6.72 ± 1.13） mg · L^-1; tmax （0.84 ± 0.76）, （1.04 ± 0.91 ） h; t1/2（ke）（25.93 ± 4.33）, （25.93 ±5.70） h; AUC0-t（212.47 ± 29.54）, （208.80 ± 31.56） mg ·h · L^-1; AUC0-t （224.74 ± 30.99）, （221.79 ± 32.46）mg ·h · L^-1, respectively. F0-t and F0-∞ of test preparation were （ 102.53 ± 11.04）%, （ 102.03 ± 10.95 ）%, respectively. Conclusion： The test preparation is bioequivalent to the reference preparation.