Delving into the Latest Updates on Shandong Hubble Kisen Biological Technology Co Ltd with Synapse

Overview

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Neoplasms

Skin and Musculoskeletal Diseases

Other Diseases

Small molecule drug

Disease domain score

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Technology Platform

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Disease Domain	Count

Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	1

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Tubulin	1

主要研究目的：考察中国健康受试者在空腹/餐后条件下单剂量口服山东华铂凯盛生物科技有限公司提供的受试制剂布瑞哌唑片（规格：2mg）与 Otsuka Pharmaceutical Co., Ltd. 生产的参比制剂布瑞哌唑片（商品名：REXULTI®；规格：2mg）后的体内药代动力学特征，评价两制剂的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the in vivo pharmacokinetic characteristics of the test preparation brepirazole tablets (specification: 2 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and the reference preparation brepirazole tablets (trade name: REXULTI®; specification: 2 mg) produced by Otsuka Pharmaceutical Co., Ltd. in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Feb 2024

Sponsor / Collaborator

Shandong Hubble Kisen Biological Technology Co Ltd

CTR20233675 / CompletedNot Applicable

枸橼酸西地那非片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of sildenafil citrate tablets in healthy subjects under fasting and fed conditions

主要目的比较空腹和餐后给药条件下，山东华铂凯盛生物科技有限公司提供的枸橼酸西地那非片（100 mg）与辉瑞制药有限公司持证的枸橼酸西地那非片（100 mg，商品名：万艾可®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹和餐后给药条件下，山东华铂凯盛生物科技有限公司提供的枸橼酸西地那非片（100 mg）与辉瑞制药有限公司持证的枸橼酸西地那非片（100 mg，商品名：万艾可®）在健康成年人群中的安全性。

[Translation]

Main purpose To compare the differences in the extent and rate of absorption of sildenafil citrate tablets (100 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and sildenafil citrate tablets (100 mg, trade name: Viagra®) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary purpose To evaluate the safety of sildenafil citrate tablets (100 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and sildenafil citrate tablets (100 mg, trade name: Viagra®) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions.

Start Date11 Dec 2023

Sponsor / Collaborator

Shandong Hubble Kisen Biological Technology Co Ltd

CTR20233288 / CompletedNot Applicable

比拉斯汀片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹状态下的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of bilastine tablets in healthy subjects under fasting conditions

主要目的比较空腹给药条件下，山东华铂凯盛生物科技有限公司研制的比拉斯汀片（20mg）与Menarini International Operations Luxembourg S.A.持证的比拉斯汀片（20mg；商品名：Bilaska®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹给药条件下，山东华铂凯盛生物科技有限公司研制的比拉斯汀片（20mg）与Menarini International Operations Luxembourg S.A.持证的比拉斯汀片（20mg；商品名：Bilaska®）的安全性。

[Translation]

Primary objective To compare the differences in the extent and rate of absorption of Bilastine Tablets (20 mg) developed by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and Bilastine Tablets (20 mg; trade name: Bilaska®) licensed by Menarini International Operations Luxembourg S.A. in healthy adults under fasting conditions, and to evaluate their bioequivalence. Secondary objective To evaluate the safety of Bilastine Tablets (20 mg) developed by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and Bilasine Tablets (20 mg; trade name: Bilaska®) licensed by Menarini International Operations Luxembourg S.A. under fasting conditions.

Start Date21 Nov 2023

Sponsor / Collaborator

Shandong Hubble Kisen Biological Technology Co Ltd

100 Clinical Results associated with Shandong Hubble Kisen Biological Technology Co Ltd

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0 Patents (Medical) associated with Shandong Hubble Kisen Biological Technology Co Ltd

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100 Deals associated with Shandong Hubble Kisen Biological Technology Co Ltd

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100 Translational Medicine associated with Shandong Hubble Kisen Biological Technology Co Ltd

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Pipeline

Pipeline Snapshot as of 05 Nov 2024

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

Phase 1 Clinical

1

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