替诺昔康片人体生物等效性研究

Study on the bioequivalence of tenoxicam tablet in healthy volunteers

目的 以Mobiflex片为参比药物 ,研究替诺昔康片的人体药代动力学和相对生物利用度 ,以判断两种制剂是否具有生物等效性。方法 2 4名健康志愿者随机分组交叉自身对照给药 ,每次服药后 2 4 0h内多点采血 ,HPLC法测定血清中药物浓度。结果 两制剂的血药浓度经时变化基本一致 ,替诺昔康片和Mobiflex片的主要药代动力学参数分别为 :T1/2Ke(6 9 6 8± 12 5 6 )h ,(6 8 75± 13 39)h ;Cmax(2 95±0 5 0 )mg·L-1,(2 82± 0 4 8)mg·L-1;AUC0～t(2 0 9 70±32 4 3)mg·L-1·h-1,(2 0 0 6 5± 18 5 7)mg·L-1·h-1;AUC0～∞(2 2 8 4 5± 36 0 7)mg·L-1 h-1,(2 18 11± 2 1 34)mg·L-1·h-1;Tmax(2 75± 1 0 7)h ,(2 75± 1 11)h ,经配对t检验差异均无显著性。替诺昔康片相对生物利用度为10 5 0 6 %± 16 6 1% (99 2 5 %～ 110 87% )。

AIM To compare the pharmacokinetics and relative bioavailability between tenoxicam tablet and mobiflex in healthy volunteers METHODS Serum concentrations of tenoxicam were measured by HPLC method following single oral doses of the two preparations given to 24 healthy volunteers in a randomized 2 way crossover study RESULTS The serum concentration time curves and pharmacokinetics of the two products were similar Main pharmacokinetic parameters of tenoxicam tablet and mobiflex were: T 1/2Ke (69 68±12 56) and (68 75±13 39) h; C max (2 95±0 50) and (2 82±0 48) mg·L -1 ;AUC 0～t (209 70±32 43) and (200 65±18 57) mg·L -1 ·h -1 ;AUC 0～∞ (228 45±36 07) and (218 11 ±21 34) mg·L -1 ·h -1 ; T max (2 75 ±1 07) and (2 75±1 11) h respectively Variance analysis and two one sided statistic tests were performed to parameters: C max , AUC 0～t There were no significant differences The relative bioavailability of tenoxicam tablet was 105 06%±16 61%(99 25%～110 87%). CONCLUSION Tenoxicam tablet and Mobiflex were bioequivalent