重组人生长激素2种制剂人体生物等效性研究

目的:评价重组人生长激素(rhGH)注射液(2种规格:T1和T2)与注射用rhGH冻干粉针剂(参比制剂,R)的人体生物等效性。方法:运用随机、单盲、三阶段交叉方法分别对24名健康男性志愿者单次皮下注射0.2IU·kg-1的R,T1和T2。测定不同时间点生长激素血药浓度,并进行相关药动学参数分析。结果:T1,T2的AUC0～24的90%置信区间分别落在R的103.4%～116.5%和105.7%～119.6%范围内,T1的AUC0～24的90%置信区间落在T2的91.9%～103.7%范围内;T1和T2的cmax的90%置信区间分别落在R的91.9%～114.0%和103.7%～127.2%范围内,T1的cmax的90%置信区间亦落在T2的81.6%～97.4%的范围内。tmax在R及T1,T2间无统计学差异(P>0.05)。结论:T1,T2与R具有生物等效性。

Study on bioequivalence between two kinds of recombinant human growth hormone

AIM: To evaluate the bioequivalence between recombinant human growth hormone (rhGH) injection(2 standard: T1 and T2)and rhGH for injection(R). METHODS: The study drugs were tested in a randomized, single-blind and three-period crossover study in 24 healthy males. The three drugs were administered by subcutaneous injection at a single dose of 0.2 IU·kg~(-1) per body weight. The venous blood samples were collected at different time points to test the serum concentrations of growth hormone(GH). RESULTS:The 90 % confidence intervals(CI) of T1,T2 AUC_(0-24) between three products were as follows: 103.4 %-116.5 % and 105.7 %-119.6 %, that of T1 AUC_(0-24) was 91.9 %-103.7 % of T2 extent. The CIs of T1,T2 c_(max) between three products were as follows: 91.9 %-114.0 % and 103.7 %-127.2 %, and CI of T1 c_(max) was in 81.6 %-97.4 % of the T2 extent. There was no significant difference of t_(max) between all the three products statistically (P>0.05). CONCLUSION:There is bioequivalent between rhGH for reconstitution and two liquid formulations of rhGH.