【摘要】 目的:评价单一给药后受试制剂（重组人生长激素注射液）和参比制剂（注射用重组人生长激素）的生物等效性及安全性。方法:研究采用单中心、双周期、随机、盲法、自身交叉对照设计。将48例受试者平均分为2组，每组受试者分别在2个周期交叉皮下注射重组人生长激素（r-hGH）受试制剂或参比制剂0.067 mg·kg^-1(0.2 IU·kg^-1),每次给药之间有3 d的洗脱期。通过比较受试制剂和参比制剂的主要药动学（PK）参数的几何平均值比率90%置信区间（90%CI）来判断生物等效性。结果:健康受试者皮下注射重组人生长激素受试制剂和参比制剂峰浓度(C_max)和曲线下面积(AUC_0-t和AUC_0-∞)的90%CI均在80%～125%的可接受范围内。表明受试制剂与参比制剂之间具有生物等效性。受试制剂和参比制剂的不良事件和不良反应的类型和发生率相似。结论:该受试制剂是已上市的重组人生长激素冻干注射剂的良好替代品，将为患者提供更多的治疗选择。更多还原

【Abstract】 Objective: To evaluate the bioequivalence and safety of the test formulation（liquid recombinant human growth hormone injection） and the reference formulation（lyophilized powder recombinant human growth hormone injection） after a single administration. Methods: A single centered, 2-period, randomized, blinded, self-cross-controlled trial was adopted. A total of 48 subjects involved were equally divided into 2 groups. Subjects in each group were injected subcutaneously with recombinant human growth hormone（r-hGH） test formulation or reference formulation at 0.067 mg·kg^-1(0.2 IU·kg^-1) in two periods with a 3-day wash-out period between each administration. The bioequivalence was evaluated by comparing 90% confidence interval（CI） of the geometric mean ratio of the main PK parameters of the test formulation and the reference formulation. Results: 90%CI of maximum concentration(C_max) and area under the curve(AUC_0-t and AUC_0-∞) fell within the acceptable range of 80% to 125%, indicating that the test formulation and the reference formulation are bioequivalent. The type and incidence of adverse events and adverse reactions of both formulations were similar. Conclusion: The test formulation is a good substitute for the marketed r-hGH lyophilized powder injection, which will provide more options for the treatments of Chinese patients with growth hormone deficiency（GHD）.更多还原