[Translation] A single-center, randomized, double-blind, two-period, crossover, single subcutaneous pharmacokinetic and safety comparison study of HB1082 and Futaio in Chinese healthy subjects
主要目的:观察中国健康受试者单次皮下注射20μg试验药HB1082(特立帕肽注射液)(规格:20μg:80μL ,2.4mL/支;生产厂家:无锡和邦生物科技有限公司,提供企业:无锡和邦生物科技有限公司)和参照药特立帕肽注射液(商品名:复泰奥;规格:20μg:80 μL,2.4mL/支;生产厂家: Lilly France公司;提供企业:无锡和邦生物科技有限公司)后的药代动力学特征,评价两种制剂的药代动力学相似性。
次要目的:比较试验药HB1082和参照药特立帕肽注射液(复泰奥)在中国健康受试者中单次皮下注射20μg的安全性和耐受性;比较试验药HB1082和参照药特立帕肽注射液(复泰奥)在中国健康受试者中单次皮下注射20μg后,血清钙浓度的变化。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the experimental drug HB1082 (teriparatide injection) (specification: 20μg:80μL, 2.4mL/vial; manufacturer: Wuxi Hebang Biotechnology Co., Ltd., provider: Wuxi Hebang Biotechnology Co., Ltd.) and the reference drug teriparatide injection (trade name: Futaio; specification: 20μg:80 μL, 2.4mL/vial; manufacturer: Lilly France; provider: Wuxi Hebang Biotechnology Co., Ltd.) in healthy Chinese subjects, and to evaluate the pharmacokinetic similarity of the two preparations.
Secondary objective: To compare the safety and tolerability of a single subcutaneous injection of 20μg of the experimental drug HB1082 and the reference drug teriparatide injection (Futaio) in healthy Chinese subjects; to compare the changes in serum calcium concentration after a single subcutaneous injection of 20μg of the experimental drug HB1082 and the reference drug teriparatide injection (Futaio) in healthy Chinese subjects.