国产美洛昔康片剂人体生物等效性研究

Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers

目的 :对国产美洛昔康片剂进行人体生物等效性研究。方法 :20名健康受试者随机交叉给药 ,分别口服单剂量美洛昔康国产片剂和进口片剂15mg,采用高效液相紫外检测法测定血浆中美洛昔康的浓度。结果 :经3p97生物等效性程序计算处理 ,美洛昔康国产片剂和进口标准参比制剂的AUC0～t 分别为 (96454 6±25526 6) μg/(h·L)和 (95692 5±24532 6) μg(h·L) ,Tmax 分别为 (4 25±1 16)h和 (4 00±1 30)h ,Cmax 分别为 (2736 2±312 0) μg/L和 (2665 6±333 8) μg/L ,T1/2ke 分别为 (21 67±3 81)h和 (21 05±3 30)h ,经配对t检验 ,两者的AUC0～t、Tmax 、Cmax 、T1/2ke 等主要药代动力学参数无显著性差异 (P>0 05)。结论 :国产美洛昔康片剂与进口参比制剂具有生物等效性。国产美洛昔康片剂的平均相对生物利用度为 (101 3±11 9) %

OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteers METHODS:A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)method RESULTS:The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2±312 0)and(2 665 6±333 8)μg/L,respectively,the peak time(Tmax)were(4 25±1 16)h and(4 00±1 30)h,respectively,T1/2ke were(21 67±3 81)h and(21 05±3 30)h,respectively,and AUC0～t were(96 454 6±25 526 6)and(95 692 5±24 532 6)μg/(h·L),respectively There were no significant differences in AUC0～t,Tmax,Cmax and T1/2ke between two kinds of tablet CONCLUSION:The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3±11 9)%