【摘要】 目的研究氟康唑胶囊试验制剂与对照制剂的人体生物等效性,评价氟康唑在人体内的药动学。方法20名健康男性受试者随机双周期交叉单剂量口服氟康唑胶囊试验制剂和对照制剂,用HPLC内标法测定氟康唑的血药浓度,求得有关药动学参数。结果氟康唑胶囊试验制剂和对照制剂的AUC0~96 h分别为(171.36±27.25)和(175.10±22.63)mg.h.L-1,ρmax分别为(4.65±0.80)和(4.51±0.52)mg.L-1,tmax分别为(1.5±0.8)和(1.9±1.1)h。试验制剂与对照制剂相对生物利用度(F)为(97.9±9.6)%。氟康唑AUC0~96 h和ρmax经对数转换后双单侧t检验均P>0.05,试验制剂AUC0~96 h90%可信限度在对照制剂93.8%~101.2%内,ρmax90%可信限度落在对照制剂的95.3%~110.2%区间内。结论氟康唑胶囊的试验制剂与对照制剂具生物等效性。更多还原

【Abstract】 OBJECTIVE To study the bioequivalence and pharmacokinetics of the test and the reference fluconazole capsule.METHODS A single oral dose（200 mg） of the test and the reference fluconazole capsule were given to 20 healthy male volunteers in a randomized cross-over study.The fluconazole concentration in plasma was determined by HPLC.RESULTS The pharmacokinetic parameters were as follows:AUC_{0～96 h}（171.36±27.25） and（175.10±22.63）mg·h·L^-1,ρ_max（4.65±0.80） and（4.51±0.52）mg·L^-1,t_max（1.5±0.8） and（1.9±1.1）h for the test and the reference preparations,respectively.The relative bioavailability of the test to the reference was（97.9±9.6）%.The lgAUC_{0～96 h}90% confidential interval of the test capsule was in 93.8%～101.2% of the reference,that lgρ_maxwas in 95.3%～110.2% of the reference.CONCLUSION The test and the reference preparations of fluconazole are bioequivalent.更多还原