[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover-design Phase I clinical study comparing the pharmacokinetic characteristics of human growth hormone injection and Noze® in healthy adult subjects in China
主要研究目的:
研究单次皮下注射试验药人生长激素注射液(规格:30IU/10mg/3ml/瓶,吉林省奇健生物技术有限公司持有)与参照药人生长激素注射液(诺泽®,规格:1.5 ml:5 mg(NordiFlex);丹麦诺和诺德公司生产)在健康受试者体内的药代动力学特征,评价皮下注射两种制剂的生物等效性。
次要研究目的:
研究单次皮下注射试验药人生长激素注射液(规格:30IU/10mg/3ml/瓶)和参照药人生长激素注射液(诺泽®)(规格:1.5 ml:5 mg(NordiFlex))在健康受试者中的药效学特征、免疫原性和安全性。
[Translation] Primary Study Objectives:
To investigate the pharmacokinetic characteristics of a single subcutaneous injection of the investigational human growth hormone injection (30 IU/10 mg/3 ml/vial, owned by Jilin Qijian Biotechnology Co., Ltd.) compared to the reference human growth hormone injection (Noze®, 1.5 ml: 5 mg (NordiFlex); manufactured by Novo Nordisk, Denmark) in healthy volunteers, and to evaluate the subcutaneous bioequivalence of the two formulations.
Secondary Study Objectives:
To investigate the pharmacodynamic characteristics, immunogenicity, and safety of a single subcutaneous injection of the investigational human growth hormone injection (30 IU/10 mg/3 ml/vial) compared to the reference human growth hormone injection (Noze®, 1.5 ml: 5 mg (NordiFlex)) in healthy volunteers.