评估怡培生长激素注射液不同浓度制剂在健康受试者中的随机、开放、两周期、双交叉、单次皮下注射的生物利用度研究
[Translation] A randomized, open-label, two-period, double-crossover, single subcutaneous bioavailability study of different concentrations of Yipei growth hormone injection in healthy subjects
1.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂单次皮下注射给药在健康受试者中的相对生物利用度;
2.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂在健康受试者中的药代动力学(PK)特征和免疫原性;
3.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂在健康受试者中的安全性;
[Translation] 1. Evaluate the relative bioavailability of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects after single subcutaneous injection;
2. Evaluate the pharmacokinetic (PK) characteristics and immunogenicity of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects;
3. Evaluate the safety of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects;
Y 型 PEG 化重组人生长激素注射液在老年人群中的安全耐受性、药代动力学和药效动力学研究。
[Translation] Study on the safety, tolerability, pharmacokinetics and pharmacodynamics of Y-shaped PEGylated recombinant human growth hormone injection in the elderly population.
探索试验药物(Y 型 PEG 化重组人生长激素注射液,益佩生)在老年人群中的安全耐受性,以及药代动力学和药效动力学特征,为后续临床研究提供依据。
[Translation] Explore the safety and tolerability of the experimental drug (Y-type PEGylated recombinant human growth hormone injection, Yipeisheng) in the elderly population, as well as its pharmacokinetic and pharmacodynamic characteristics, to provide a basis for subsequent clinical research.
Y型PEG化重组人生长激素注射液治疗儿童矮小症的多中心、随机、开放、 阳性对照研究
[Translation] A multicenter, randomized, open, positive-controlled study of Y-shaped PEGylated recombinant human growth hormone injection in the treatment of dwarfism in children
探索益佩生治疗儿童矮小症(特发性矮小症、小于胎龄儿、先天性卵巢发育不良综合征)的药代动力学和药效学的剂量效应关系,为儿童矮小症患者的给药剂量和剂量滴定提供依据。评价益佩生治疗儿童矮小症(特发性矮小症、小于胎龄儿、先天性卵巢发育不良综合征)的安全性耐受性和疗效获益。
[Translation] To explore the pharmacokinetic and pharmacodynamic dose-effect relationship of Yipeisheng in the treatment of dwarfism in children (idiopathic dwarfism, small for gestational age, congenital ovarian hypoplasia syndrome), and provide a basis for dosing and dose titration in dwarf patients. To evaluate the safety, tolerability and efficacy benefits of Yipeisheng in the treatment of dwarfism in children (idiopathic dwarfism, small for gestational age, congenital ovarian hypoplasia syndrome).
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