[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, recombinant teriparatide injection (specification: 20 μg:80 μL, 2.4 mL/vial) and the reference preparation (Futai Ao) (specification: 20 μg:80 μL, 2.4 mL/vial) in healthy female subjects
研究单次皮下注射受试制剂重组特立帕肽注射液(规格:20 μg:80 μL,2.4 mL/支;上海联合赛尔生物工程有限公司生产)与参比制剂特立帕肽注射液(复泰奥,规格:20 μg:80 μL,2.4 mL/支;Lilly France生产)在健康女性受试者体内的药代动力学特征,评价单次皮下注射两种制剂的生物等效性。
[Translation] The pharmacokinetic characteristics of a single subcutaneous injection of the test preparation recombinant teriparatide injection (specification: 20 μg:80 μL, 2.4 mL/vial; produced by Shanghai United Cell Bioengineering Co., Ltd.) and the reference preparation teriparatide injection (Futai Ao, specification: 20 μg:80 μL, 2.4 mL/vial; produced by Lilly France) in healthy female subjects were studied, and the bioequivalence of the two preparations after a single subcutaneous injection was evaluated.