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Clinical Trials associated with Teriparatide biosimilar (Dongguan Baolijian Bioengineering)注射用重组人甲状旁腺素(1-34)Ⅰ期耐受性补充临床试验
[Translation] Phase I Tolerance Supplementation Clinical Trial of Recombinant Human Parathyroid Hormone (1-34) for Injection
选择健康志愿者,从安全的初始剂量开始,选择合适的安全性指标进行观察,补充完善人体对注射用重组人甲状旁腺素(1-34)的耐受性资料。
[Translation] Select healthy volunteers, start with a safe initial dose, choose appropriate safety indicators for observation, and supplement and improve the human body's tolerance data to recombinant human parathyroid hormone (1-34) for injection.
评价注射用重组人甲状旁腺素(1-34)在健康人体药代动力学补充临床研究
[Translation] Evaluation of the pharmacokinetics of recombinant human parathyroid hormone (1-34) for injection in healthy subjects in a supplementary clinical study
观察12名健康受试者(男女各半)单次皮下注射低、中、高剂量重组人甲状旁腺素(1-34)后的药代动力学特征,以及血浆药物AUC与给药剂量的线性关系。12名受试者(男、女各半)多次皮下注射重组人甲状旁腺素(1-34)后的药代动力学特征,以及稳态时血浆药物AUC的累积指数。
[Translation] The pharmacokinetic characteristics of recombinant human parathyroid hormone (1-34) after single subcutaneous injection of low, medium and high doses were observed in 12 healthy subjects (half male and half female), as well as the linear relationship between plasma drug AUC and the administered dose. The pharmacokinetic characteristics of recombinant human parathyroid hormone (1-34) after multiple subcutaneous injections were observed in 12 subjects (half male and half female), as well as the cumulative index of plasma drug AUC at steady state.
PTH(1-34)治疗绝经后妇女骨质疏松症安全性和有效性的随机、开放、阳性药对照、多中心临床研究
[Translation] A randomized, open, active-controlled, multicenter clinical study on the safety and efficacy of PTH (1-34) in the treatment of osteoporosis in postmenopausal women
进一步验证注射用重组人甲状旁腺素(1-34)治疗绝经后妇女骨质疏松症的安全性和有效性。
[Translation] To further verify the safety and efficacy of recombinant human parathyroid hormone (1-34) for injection in the treatment of osteoporosis in postmenopausal women.
100 Clinical Results associated with Teriparatide biosimilar (Dongguan Baolijian Bioengineering)
100 Translational Medicine associated with Teriparatide biosimilar (Dongguan Baolijian Bioengineering)
100 Patents (Medical) associated with Teriparatide biosimilar (Dongguan Baolijian Bioengineering)
100 Deals associated with Teriparatide biosimilar (Dongguan Baolijian Bioengineering)