摘要
目的研究利托那韦口服液(抗病毒药)在健康人体的药代动力学与相对生物利用度,评价其生物等效性。方法18名中国男性健康志愿者随机分2组,按双周期交叉单剂量口服利托那韦参比制剂和受试制剂各600mg,用反相高效液相色谱法测定给药后不同时间点血浆中利托那韦浓度,计算药代动力学参数,并评价其生物等效性。结果利托那韦参比制剂和受试制剂的药代动力学参数:Cmax分别为(19.08±5.38),(20.63±5.60)mg·L-1;tmax分别为(2.53±0.74),(2.75±0.90)h;t1/2ke分别为(6.19±0.77),(5.88±0.91)h;AUC0-t分别为(189.35±44.81),(200.61±74.92)mg·h·L-1;AUC0-∞分别为(193.22±45.34),(204.43±76.70)mg·h·L-1。受试制剂较参比制剂的相对生物利用度F0-t为(105.04±27.33)%,F0-∞为(104.78±27.22)%。结论参比和受试制剂具有生物等效性。
Objective To study the pharmacokinetics and bioequivalence of two ritonavir solutions. Methods A single oral dose 600 mg of two formulations of ritonavir was given to 18 healthy male volunteers in an open randomized cross - over test. The plasma levels of ritonavir were detected by RP -HPLC method. The relative bioavailability and bioequivalence of ritonavir were calculated and compared. Results The main pharmacokinetic parameters of reference and test ritonavir solutions were as follow： Cmax were（ 19.08 ±5.38）mg · L^-1 and（20.63 ±5.60）mg · L^-1 ,tmax were（6. 19 ±0.77）h and（5.88 ±0.91）h,t1/2ke were（6. 19 ±0.77 ） h and（5.88 ±0.91 ） h, AUC0 -1, were （ 189.35 ± 44.81 ） mg ·h · L^-1 and（200.61 ±74.92）mg · h · L^-1 ,AUC0-∞ were（ 193.22 ±45. 34） mg · h · L^ - 1 and （ 204.43 ± 76.70 ） mg · h · L^-1, respectively. The relative bioavailability were F0-1 = （105. 04 ±27. 33）%,F0-∞ = （ 104.78 ±27.22） %. Conclusion The results of statistics analysis shown that the test and reference ritonavir solutions are bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第5期332-335,共4页
The Chinese Journal of Clinical Pharmacology
