Bioequivalence Between rhGH for Reconstitution and Ready-to-Use rhGH in Two Liquid Formulations

作     者：ZHANC Yi-fei DU Peng-fei XU Min ZHANG Yi ZHANG Lian-zhen WANG Wei-qin ZHAO Yong-ju NING Guang 

作者机构：Shanghai Clinical Center for Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases Ruifin Hospital School of MedicineShanghai Jiaotong University Shanghai 200025 China 

出 版 物：《上海交通大学学报（医学版）》 (Journal of Shanghai Jiao tong University:Medical Science)

年 卷 期：2006年第26卷第3期

页      面：240-240页

核心收录：

学科分类：0710[理学-生物学] 071010[理学-生物化学与分子生物学] 081704[工学-应用化学] 07[理学] 08[工学] 0817[工学-化学工程与技术] 

主　　题：重组人生长激素 rhGH 生长激素抑制素 生物当量 

摘      要：Objective To evaluate the bioequivalence between recombinant human growth hormone (rhGH) for reconstitution, and two dosages of liquid formulation of rhGH [(15 IU)5 mg or (30 IU)10 mg per 3 mL]. Methods The study drugs were tested in a randomized, single-blind and three-period crossover studies in 24 healthy!male subjects. The three drugs were administered by subcutaneous injection at a dose of 0.2 IU/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The venous blood samples were drawn at different time points to test the serum concentration of GH. The pharmacokinetic parameters were analyzed by statistical methods. Results 90% confidence intervals (CI) of AUC_ 0-24 h among three products were all within 80%~125% interval (103.4%~116.5%, 105.7%~119.6% and 91.9%~103.7%, respectively), and the CIs of C_ max among three products were all within 70%~143% interval (91.9%~114.0%, 103.7%~127.2% and 81.6% ~97.4%, respectively). There was no statisitical difference of t_ max among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH.