[Translation] A single-center, randomized, open-label, single-dose, fasting intramuscular injection bioequivalence study of salmon calcitonin injection (1 mL: 50 IU) in healthy Chinese adult participants: a two-formulation, two-period, double-crossover bioequivalence study
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:50 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®,密盖息®;规格:1 mL:50 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®,密盖息®)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 a single fasting intramuscular injection of salmon calcitonin injection (strength: 1 mL: 50 IU) developed by Yingu Pharmaceutical Co., Ltd. as the test formulation (T) and the reference formulation (R) of salmon calcitonin injection (trade name: Miacalcic®; strength: 1 mL: 50 IU) licensed by Future Health Pharma GmbH in healthy Chinese adults, and to investigate the bioequivalence of the two formulations. Secondary Objective: To observe the safety and immunogenicity of the test and reference formulations of salmon calcitonin injection (trade name: Miacalcic®) in healthy participants.