[Translation] A randomized, open-label, single-dose, two-preparation, two-sequence, two-period, self-crossover controlled study was conducted to evaluate the bioequivalence of a single subcutaneous injection of the test preparation progesterone injection and the reference preparation progesterone injection (trade name: Prolutex®) in healthy Chinese subjects.
主要目的:观察健康受试者空腹状态下单剂量皮下注射受试制剂黄体酮注射液(规格:1.112mL:25mg,申办方:浙江百代医药科技有限公司,生产厂家:浙江赛默制药有限公司)后血药浓度的经时过程,估算相应的药代动力学参数;并以持证商为IBSA Farmaceutici Italia Srl的黄体酮注射液(商品名:Prolutex®,规格:1.112mL:25mg)为参比制剂,进行人体生物等效性正式试验,为该药注册申报和临床应用提供参考依据。
次要目的:观察受试者空腹状态下皮下注射受试制剂和参比制剂的安全性。
[Translation] The main purpose is to observe the time course of blood drug concentration after a single dose of subcutaneous injection of the test preparation progesterone injection (specification: 1.112mL: 25mg, applicant: Zhejiang Baidai Pharmaceutical Technology Co., Ltd., manufacturer: Zhejiang Thermo Pharmaceutical Co., Ltd.) in healthy subjects in the fasting state, and estimate the corresponding pharmacokinetic parameters; and use the progesterone injection (trade name: Prolutex®, specification: 1.112mL: 25mg) of the license holder IBSA Farmaceutici Italia Srl as the reference preparation to conduct a formal human bioequivalence test to provide a reference for the registration and clinical application of the drug.
Secondary purpose: Observe the safety of subcutaneous injection of the test preparation and the reference preparation in the fasting state of the subjects.