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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date30 Dec 2019 |
/ Not yet recruitingNot Applicable 肌内注射鲑降钙素注射液在成年健康绝经期妇女受试者中的随机、开放、单次给药、两制剂、两序列、四周期交叉的药代动力学比对研究
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period crossover pharmacokinetic study of intramuscular salmon calcitonin injection in healthy adult menopausal women
主要研究目的:
观察单次肌内注射受试制剂鲑降钙素注射液(规格:1mL:50IU)与参比制剂鲑降钙素注射液(商品名:密盖息®,规格:1mL:50IU,持证商Future Health Pharma GmbH)在健康成年绝经期妇女受试者中的药代动力学(PK)特征的相似性。
次要研究目的:
观察受试制剂鲑降钙素注射液(1mL:50IU)与参比制剂鲑降钙素注射液在健康成年绝经期妇女受试者的安全性。
[Translation] Main study objectives:
To observe the similarity of the pharmacokinetic (PK) characteristics of a single intramuscular injection of the test preparation salmon calcitonin injection (specification: 1mL:50IU) and the reference preparation salmon calcitonin injection (trade name: Miacalci®, specification: 1mL:50IU, licensee Future Health Pharma GmbH) in healthy adult menopausal women.
Secondary study objectives:
To observe the safety of the test preparation salmon calcitonin injection (1mL:50IU) and the reference preparation salmon calcitonin injection in healthy adult menopausal women.
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