2种氯雷他定片剂的人体相对生物利用度试验

目的:比较2种氯雷他定片(LORAX和LORAS)在人体的相对生物利用度。方法:22名健康男性志愿者交叉单剂量(20mg)口服LORAX片或LORAS片,高效液相色谱法测定其血浆中氯雷他定浓度,3p97程序计算药动学参数。结果:LORAX片和LORAS片的t1/2Ke分别为(3.03±0.98)h、(2.65±0.81)h;Cmax为(8.59±6.70)、(9.59±8.22)ng/ml;tmax为(1.08±0.41)h、(1.21±0.28)h;AUC(0~t)为(27.29±24.54)、(27.92±20.64)(ng.h)/ml;LORAX的相对生物利用度为(100.63±14.27)%。结论:2种氯雷他定片具有生物等效性。

Relative Bioavailability of 2 Products of Loratadine Tablets in Human Body

OBJECTIVE:To compare the relative bioavailability between2loratadine tablets(LORAX and LORAS)in human body.METHODS:22healthy male volunteers were enrolled to receive oral single dose(20mg)of either LORAX or LORAS tablets by crossover way,plasma concentrations of loratadine were determined by HPLC and pharmacokinetic param-eters were calculated by3p97program.RESULTS:The pharmacokinetic parameters of LORAX vs.LORAS were the fol-lowing,t 1/2Ke (3.03±0.98)h vs.(2.65±0.81)h;C max (8.59±6.70)vs.(9.59±8.22)ng/ml;t max (1.08±0.41)h vs.(1.21±0.28)h;AUC (0～t) (27.29±24.54)vs.(27.92±20.64)(ng·h)/ml.The relative bioavailability of LORAX was(100.63±14.27)%.CONCLUSION:2loratadine tablets were bioequivalent.