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| BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS | |
| 引用本文： | 张翼飞 杜鹏飞 徐敏 张毅 张连珍 王卫庆 赵咏桔 宁光. BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS[J]. 上海第二医科大学学报, 2006, 18(1): 10-14 |
| 作者姓名： | 张翼飞 杜鹏飞 徐敏 张毅 张连珍 王卫庆 赵咏桔 宁光 |
| 作者单位： | Shanghai Clinical Center for Endocrine and Metabolic Diseases, Department of Endocrine and Metabolic Diseases, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China |
| 摘 要： | Objective To evaluate the bioequivalence between recombinant human growth hormone （rhGH） for reconstitution, and two dosages of liquid formulation of rhGH [ （151U） 5mg or （301U） lOmg per 3ml ]. 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 O. 21U/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The ve- nous 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 AUC0-24h 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 Cls of C,~ 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 tmax among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH. |
| 关 键 词： | 生物等效性 rhGH 生长激素抑制素 重组体 表达方式 |
| 收稿时间： | 2005-03-21 |
BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS |
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| ZHANG Yi-fei,DU Peng-fei,XU Min,ZHANG Yi,ZHANG Lian-zhen,WANG Wei-qin,ZHAO Yong-ju,NING Guang. BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS[J]. Journal of Shanghai Second Medical University(Foreign Language Edition), 2006, 18(1): 10-14 | |
| Authors: | ZHANG Yi-fei DU Peng-fei XU Min ZHANG Yi ZHANG Lian-zhen WANG Wei-qin ZHAO Yong-ju NING Guang |
| Abstract: | Objective To evaluate the bloequivalence between recombinant human growth hormone ( rh- GH) for reconstitution, and two dosages of liquid formulation of rhGH [ (I5IU)5mg or (30IU) 10mg per 3ml]. 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. 2IU/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 AUC0-24h 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 Cmax 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 tmax among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH. |
| Keywords: | recombinan thuman growth hormone rhGH somatostatin bioequivalence |
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