[Translation] A single-center, randomized, open-label, single fasting intramuscular injection, two-dose, two-period, double-crossover bioequivalence study of salmon calcitonin injection in healthy Chinese adult participants
主要目的:以银谷制药有限责任公司研制的鲑降钙素注射液(规格:1 mL:100 IU)为受试制剂(T),以Future Health Pharma GmbH持证的鲑降钙素注射液(商品名:Miacalcic®;规格:1 mL:100 IU)为参比制剂(R),对比在中国健康成年参与者中单次空腹肌内注射给药的药代动力学特征,考察两制剂的人体生物等效性。
次要目的:观察鲑降钙素注射液受试制剂和参比制剂(商品名:Miacalcic®)在健康参与者中的安全性和免疫原性。
[Translation] Primary objective: To compare the pharmacokinetic characteristics of single fasting intramuscular injection in healthy adult participants in China using salmon calcitonin injection (specification: 1 mL: 100 IU) developed by Yingu Pharmaceutical Co., Ltd. as the test preparation (T) and salmon calcitonin injection (trade name: Miacalcic®; specification: 1 mL: 100 IU) certified by Future Health Pharma GmbH as the reference preparation (R), and to investigate the bioequivalence of the two preparations in humans.
Secondary objective: To observe the safety and immunogenicity of the test preparation and reference preparation (trade name: Miacalcic®) of salmon calcitonin injection in healthy participants.