[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;