[Translation] A randomized, open-label, four-period, completely repeated crossover clinical study with fasting and fed administration to evaluate the bioequivalence of tacrolimus capsules and Prograf in healthy Chinese adult subjects

主要目的：以浙江仙琚医药科技有限公司持有的他克莫司胶囊（1mg）为受试制剂，按生物等效性试验的有关规定，与Astellas Pharma Co.Ltd.持有的他克莫司胶囊（商品名：普乐可复，规格：1mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹和餐后条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（他克莫司胶囊，T）和参比制剂（普乐可复，R）在中国健康成年受试者中的安全性。

[Translation]

Primary objective: To conduct a bioequivalence study using tacrolimus capsules (1 mg) held by Zhejiang Xianju Pharmaceutical Technology Co., Ltd. as the test preparation and tacrolimus capsules (trade name: Prograf, specification: 1 mg) held by Astellas Pharma Co., Ltd. as the reference preparation according to the relevant provisions of the bioequivalence study, and to compare the bioequivalence of the two preparations under fasting and postprandial conditions after a single dose. Secondary objective: To evaluate the safety of a single oral dose of the test preparation (tacrolimus capsules, T) and the reference preparation (Prograf, R) in healthy adult subjects in China.

Start Date17 Sep 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Technology Co., Ltd.

CTR20242504 / RecruitingNot Applicable

噻托溴铵吸入粉雾剂在慢性阻塞性肺疾病试验参与者中的多中心、随机、双盲、交叉的药效动力学生物等效性研究

[Translation] A multicenter, randomized, double-blind, crossover pharmacodynamic bioequivalence study of tiotropium bromide inhalation powder in participants of a chronic obstructive pulmonary disease trial

主要目的：以浙江仙琚医药科技有限公司持有的噻托溴铵吸入粉雾剂为受试制剂，以原研厂家Boehringer Ingelheim International GmbH持证的噻托溴铵吸入粉雾剂（商品名：思力华®）为参比制剂，在慢性阻塞性肺疾病试验参与者中，评价FEV1-AUC0-24h在受试制剂和参比制剂间的等效性。次要目的：观察受试制剂和参比制剂在慢性阻塞性肺疾病试验参与者中的安全性。

[Translation]

Main purpose: Tiotropium inhalation powder held by Zhejiang Xianju Pharmaceutical Technology Co., Ltd. was used as the test preparation, and Tiotropium inhalation powder (trade name: Spiriva®) certified by the original manufacturer Boehringer Ingelheim International GmbH was used as the reference preparation to evaluate the equivalence of FEV1-AUC0-24h between the test preparation and the reference preparation in participants with chronic obstructive pulmonary disease. Secondary purpose: Observe the safety of the test preparation and the reference preparation in participants with chronic obstructive pulmonary disease.

Start Date22 Aug 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Technology Co., Ltd.

CTR20242935 / Active, not recruitingNot Applicable

丁苯酞软胶囊空腹人体生物等效性研究

[Translation] Study on the bioequivalence of butylphthalide soft capsules in fasting volunteers

本试验旨在研究单次空腹口服浙江仙琚制药股份有限公司研制、生产的丁苯酞软胶囊（0.1 g）的药代动力学特征；以石药集团恩必普药业有限公司生产的丁苯酞软胶囊（恩必普®，0.1 g）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to study the pharmacokinetic characteristics of a single fasting oral administration of butylphthalide soft capsules (0.1 g) developed and produced by Zhejiang Xianjun Pharmaceutical Co., Ltd.; using butylphthalide soft capsules (Enbipu®, 0.1 g) produced by CSPC Pharmaceutical Group Enbipu Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

Start Date06 Aug 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhejiang Xianju Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Zhejiang Xianju Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Zhejiang Xianju Pharmaceutical Co., Ltd.

07 Feb 2024·Journal of Agricultural and Food Chemistry

Study on the Digestive Behavior of Chlorogenic Acid in Biomimetic Dietary Fiber and the Antioxidative Synergistic Effect of Polysaccharides and Chlorogenic Acid

Article

Author: Ren, Xue-Ning ; Zhang, Yue ; Zhang, Wen ; Zhang, Qian-Yu ; Li, Ji ; Niu, Qiao

Chlorogenic acid (CA) is often combined with dietary fiber polysaccharides in plant foods, which may affect its digestive behavior and antioxidant activity. This study constructed a biomimetic dietary fiber (BDF) model by combining bacterial cellulose (BC) and pectin with CA and investigated the digestive behavior of CA in BDF. Additionally, the study examined the interaction and synergistic effects of polysaccharides and CA against oxidation. Results showed that BDF and natural dietary fiber had similar microstructures, group properties, and crystallization properties, and polysaccharides in BDF were bound to CA. After simulated gastrointestinal digestion, 41.03% of the CA existed in a conjugated form, and it was possibly influenced by the interaction between polysaccharides and CA. And the release of CA during simulated digestion potentially involved four mechanisms, including the disintegration of polysaccharide-CA complex, the dissolution of pectin, escape from BC-pectin (BCP) network structure, and diffusion release. And polysaccharides and CA may be combined through noncovalent interactions such as hydrogen bonding, van der Waals force, or electrostatic interaction force. Meanwhile, polysaccharides-CA combination had a synergistic antioxidant effect by the results of free-radical scavenging experiments, it was probably related to the interaction between polysaccharides and CA. The completion of this work has a positive significance for the development of dietary intervention strategies for oxidative damage.

12 Dec 2023·Microbiology Spectrum

Assessing airborne transmission risks in COVID-19 hospitals by systematically monitoring SARS-CoV-2 in the air

Article

Author: He, Ming ; Gu, Yin ; Yang, Shangzhi ; Meng, Yan ; Yang, Yi ; Lu, Lianhe ; Guo, Jiazhen ; Liu, Peng ; Jin, Ronghua ; Ge, Ziruo ; Li, Shanglin ; Wang, Guanjun

ABSTRACTThe continuous emergence of highly infectious SARS-CoV-2 variants with the capability of immune evasion demands more effective risk assessment and management approaches for infection prevention and control. Controlling nosocomial transmission is critical in response to the COVID-19 pandemic upon the resumption of day-to-day activities. Here, we systematically analyzed the presence of airborne SARS-CoV-2 in the isolation ward and within the contaminant, emergency, and clean zones of a designated COVID-19 hospital. A total of 359 air samples collected in the clean and emergency zones tested negative for SARS-CoV-2, demonstrating the interruption of airborne transmission in a designated COVID-19 hospital by combining the closed-loop management, unidirectional airflow, and negative pressure of isolation wards. In contrast, some air samples in the corridor outside the isolation wards tested positive for SARS-CoV-2. The leakage of virus-containing air from patient rooms to adjoining areas during rounds and meal delivery sheds light on the need for intensive and widespread virus monitoring in designated COVID-19 hospitals. In conclusion, by systematically monitoring viruses in the air, the study provides a starting point for the standardization of transmission risk management in designated hospitals for the future pandemic of a newly emerged respiratory infectious disease.IMPORTANCERisk management and control of airborne transmission in hospitals is crucial in response to a respiratory virus pandemic. However, the formulation of these infection control measures is often based on epidemiological investigations, which are an indirect way of analyzing the transmission route of viruses. This can lead to careless omissions in infection prevention and control or excessively restrictive measures that increase the burden on healthcare workers. The study provides a starting point for standardizing transmission risk management in designated hospitals by systemically monitoring viruses in the air of typical spaces in COVID-19 hospitals. The negative results of 359 air samples in the clean and emergency zones demonstrated the existing measures to interrupt airborne transmission in a designated COVID-19 hospital. Some positive cases in the corridor of the contaminant zone during rounds and meal delivery highlighted the importance of monitoring airborne viruses for interrupting nosocomial infection.

01 May 2023·Journal of Colloid and Interface Science

The effects of size and surface functionalization of polystyrene nanoplastics on stratum corneum model membranes: An experimental and computational study

Article

Author: Shang, Yazhuo ; Liu, Honglai ; Hu, Jiajie ; Cheng, Shiqiang ; Guo, Chen ; Ye, Zhicheng ; Lian, Cheng

Nanoplastics are mainly generated from the decomposition of plastic waste and artificial production and have attracted much attention due to their wide distribution in the environment and the potential risk for humans. As the largest organ of the human body, the skin is inevitably in contact with nanoplastics. Stratum corneum is the first barrier when the skin is exposed to nanoplastics. However, little is known about the interactions between nanoplastics and stratum corneum. Here, the effects of particle size and surface functionalization (amino-modified and carboxy-modified) of polystyrene nanoplastics on the stratum corneum models were studied by Langmuir monolayer and molecular dynamics simulations. An equimolar mixture of ceramide/cholesterol/free fatty acid was used to mimic stratum corneum intercellular lipids. The Langmuir monolayer studies demonstrated that the larger size and surface functionalization of polystyrene nanoplastics significantly reduced the stability of stratum corneum lipid monolayer in a concentration-dependent fashion. Simulation results elucidated that functionalized polystyrene oligomers had a stronger interaction with lipid components of the stratum corneum model membrane. The cell experiments also indicated that functionalized polystyrene nanoplastics, especially for amino-modified polystyrene nanoplastics, had significant cytotoxicity on normal human dermal fibroblast cells. Our results provide fundamental information and the basis for a deeper understanding of the health risks of nanoplastics to humans.

100 Deals associated with Zhejiang Xianju Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Zhejiang Xianju Pharmaceutical Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Norethisterone Enanthate ( PR )	Infertility More	Approved
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Adamgammadex Sodium	Reversal of Neuromuscular Blockade More	NDA/BLA
Ulipristal Acetate ( PR )	Contraception More	Phase 3
Beclometasone Dipropionate ( GR )	Asthma More	Phase 3

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