Safety, tolerability and pharmacokinetic study of recombinant human parathyroid hormone in healthy male Chinese subjects |
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引用本文: | LI Wei-yong LI Qian QIAO Jian DENG Jun-gang ZHANG Ying. Safety, tolerability and pharmacokinetic study of recombinant human parathyroid hormone in healthy male Chinese subjects[J]. 中国临床药理学与治疗学, 2007, 12(10): 1182-1183 |
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作者姓名: | LI Wei-yong LI Qian QIAO Jian DENG Jun-gang ZHANG Ying |
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作者单位: | Institute of Clinic Pharmacy, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science & Technology, Wuhan 430022, Hubei , China |
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摘 要: | AIM: To determine the safety, tolerability and pharmacokinetic parameters of a new drug recombinant human parathyroid hormone [ rhPTH (1-84)] in healthy male Chinese subjects. METHODS: domly divided Thirty-six healthy male volunteers were rangroups received into 3 groups. The volunteers in these single subcutaneous injection of rhPTH ( 1-84) in a dosage of 1, 2 and 4 μg/kg respectively. Blood samples were obtained before and after administration within 24 hours. The rhPTH concentrations in sennn were determined by enzyme linked immunosorbent assay (ELISA). The pharmacokinetic parameters determined with use of standard noncompartmental analysis were the maximum serum concentration ( Cmax ), the time to attain that concentration ( tmax ), and the area under the serum concentration-time curve up to 24 hours( AUC0-24 ) and up to infinity (AUC0-∞). Dose proportionality of pharmacokinetic parameters (AUC, Cmax of every volunteer of each dosage and A UC was computed from log transformed data) and was examined by mean of analysis of variance (ANOVA) using SPSS software package. In the study, subjects' symptoms, objective signs, and vital signs, including blood pressure, heart rate, respiratory rate and body temperature, were checked and 12-lead electrocardiography was recorded before and after drug administration within 24 hours. Routine laboratory tests, including hematology, blood biochemistry, serum electrolyte, and urinalysis, were performed before and after drug administration within at 24 hours.[第一段]
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关 键 词: | 重组人甲状旁腺激素 中国 男性 健康受试者 安全性 药物代谢动力学 |
Safety, tolerability and pharmacokinetic study of recombinant human parathyroid hormone in healthy male Chinese subjects |
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Abstract: | |
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Keywords: | recombinant human parathyroid hormone tolerability safety pharmacokinetics single dose |
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