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MechanismTop II inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jun 2021 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1995 |
注射用柔红霉素阿糖胞苷脂质体在老年初治或诱导缓解的AML受试者中进行的随机、开放、两周期、两交叉生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover bioequivalence trial of daunorubicin cytarabine liposome for injection in elderly subjects with untreated or induced remission AML
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] Evaluation of the test preparation (daunorubicin cytarabine liposome for injection) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference preparation (daunorubicin for injection) of Jazz Pharmaceutical Co., Ltd. Glycocytidine liposomes, trade name: Vyxeos) bioequivalence.
比较盐酸米托蒽醌脂质体注射液联合卡培他滨与卡培他滨单药用于含铂治疗失败的复发转移性鼻咽癌受试者的随机、开放、阳性对照、多中心Ш期临床研究
[Translation] Comparison of mitoxantrone hydrochloride liposome injection combined with capecitabine and capecitabine alone in the treatment of patients with recurrent and metastatic nasopharyngeal carcinoma who failed platinum-based therapy phase clinical study
主要研究目的:
评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性。 次要研究目的:
评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性和安全性;
评价盐酸米托蒽醌脂质体注射液的药代动力学(PK)特征。
[Translation] Main research purposes:
To evaluate the effectiveness of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent and metastatic nasopharyngeal carcinoma. Secondary research purposes:
To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent and metastatic nasopharyngeal carcinoma;
To evaluate the pharmacokinetic (PK) characteristics of mitoxantrone hydrochloride liposome injection.
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-cycle, two-crossover bioequivalence trial of clevidipine butyrate injection emulsion 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] Main purpose: To study the intravenous infusion of the test preparation clevidipine butyrate injection emulsion (produced by Shijiazhuang Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) and the reference preparation clevidipine butyrate injection emulsion (Cleviprex®, Fresenius Pharmacokinetics of Kabi Austria GmbH (Austria) in healthy subjects to evaluate the bioequivalence of the two formulations by intravenous infusion. Secondary objective: To study the safety of intravenous infusion of test preparation clevidipine butyrate emulsion for injection and reference preparation Cleviprex® in healthy subjects.
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.