[Translation] A randomized, open-label, two-period, two-crossover bioequivalence trial of daunorubicin cytarabine liposomal injection in elderly subjects with AML who were undergoing initial treatment or induced remission

评价石药集团中诺药业(石家庄)有限公司生产的受试制剂（注射用柔红霉素阿糖胞苷脂质体）与Jazz制药有限公司的参比制剂（注射用柔红霉素阿糖胞苷脂质体，商品名：Vyxeos）的生物等效性。

[Translation]

To evaluate the bioequivalence of the test preparation (daunorubicin cytarabine liposome for injection) produced by Shijiazhuang Sinopharm Pharmaceutical Co., Ltd. and the reference preparation (daunorubicin cytarabine liposome for injection, trade name: Vyxeos) produced by Jazz Pharmaceuticals Co., Ltd.

Start Date07 Aug 2023

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

CTR20222282

/ CompletedNot Applicable

丁酸氯维地平注射用乳剂随机、开放、两周期、两交叉健康受试者生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of clevidipine butyrate emulsion for injection in healthy subjects

主要目的：研究静脉输注受试制剂丁酸氯维地平注射用乳剂（石药集团中诺药业（石家庄）有限公司生产）与参比制剂丁酸氯维地平注射用乳剂（Cleviprex®，Fresenius Kabi Austria GmbH（奥地利）公司生产）在健康受试者体内的药代动力学，评价静脉输注两种制剂的生物等效性。次要目的：研究静脉输注受试制剂丁酸氯维地平注射用乳剂和参比制剂Cleviprex® 在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of the test preparation clevidipine butyrate injection emulsion (produced by Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd., China Pharmaceutical Group) and the reference preparation clevidipine butyrate injection emulsion (Cleviprex®, produced by Fresenius Kabi Austria GmbH (Austria)) in healthy subjects after intravenous infusion, and to evaluate the bioequivalence of the two preparations after intravenous infusion. Secondary objective: To study the safety of the test preparation clevidipine butyrate injection emulsion and the reference preparation Cleviprex® in healthy subjects after intravenous infusion.

Start Date15 Sep 2022

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

CTR20221520

/ CompletedNot Applicable

阿瑞匹坦注射液在健康受试者中随机、开放、两制剂、单次给药、三周期、交叉生物等效性试验

[Translation] A randomized, open-label, two-dose, single-dose, three-period, crossover bioequivalence study of aprepitant injection in healthy subjects

主要研究目的：研究单次静脉输注石药集团中诺药业（石家庄）有限公司生产的受试制剂阿瑞匹坦注射液，与Heron Therapeutics,Inc.公司生产的参比制剂阿瑞匹坦注射液（商品名：CINVANTI）在健康受试者体内的药代动力学特征，评价两制剂的生物等效性。次要研究目的：评价受试制剂阿瑞匹坦注射液与参比制剂阿瑞匹坦注射液（商品名：CINVANTI）在健康受试者中的安全性，以及受试制剂阿瑞匹坦注射液两种给药方式的相对生物利用度。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation aprepitant injection produced by Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical Co., Ltd. and the reference preparation aprepitant injection (trade name: CINVANTI) produced by Heron Therapeutics, Inc. in healthy subjects after a single intravenous infusion, and to evaluate the bioequivalence of the two preparations. Secondary purpose of the study: to evaluate the safety of the test preparation aprepitant injection and the reference preparation aprepitant injection (trade name: CINVANTI) in healthy subjects, and the relative bioavailability of the test preparation aprepitant injection by two administration methods.

Start Date08 Aug 2022

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

100 Clinical Results associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

0 Patents (Medical) associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

100 Deals associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

100 Translational Medicine associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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