[Translation] A single-center, two-period, randomized, blinded, self-crossover controlled study to evaluate the bioequivalence of human growth hormone injection and human growth hormone for injection in healthy Chinese adult volunteers after single administration
主要目的:评价单次给药后人生长激素注射液与注射用人生长激素(商品名:海之元®)的主要药代动力学参数Cmax、AUC0-t、AUC0-∞的生物等效性。
次要目的:评价单次给药后人生长激素注射液与注射用人生长激素(商品名:海之元®)的其他药代动力学参数及药效动力学的相似性及用药的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the main pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of human growth hormone injection and human growth hormone for injection (trade name: Haizhiyuan®) after a single dose.
Secondary objective: To evaluate the similarity of other pharmacokinetic parameters and pharmacodynamics between human growth hormone injection and human growth hormone for injection (trade name: Haizhiyuan®) after a single dose and the safety of medication.