Delving into the Latest Updates on Changzhou Huasheng Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Immune System Diseases

Endocrinology and Metabolic Disease

Respiratory Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

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Targets

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Disease Domain	Count

Endocrinology and Metabolic Disease	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

FDPS(Farnesyl diphosphate synthase)	1
TBXA2R(Thromboxane A2 receptor)	1

主要目的： 1.研究空腹单次口服盐酸氟西汀胶囊受试制剂(20mg/粒，常州华生制药有限公司）与盐酸氟西汀胶囊参比制剂（20mg/粒，持证商：LILLY FRANCE）在中国健康受试者体内的药代动力学行为，评价空腹口服两种制剂的生物等效性。 2.研究餐后单次口服盐酸氟西汀胶囊受试制剂(20mg/粒，常州华生制药有限公司）与盐酸氟西汀胶囊参比制剂（20mg/粒，持证商：LILLY FRANCE）在中国健康受试者体内的药代动力学行为，评价餐后口服两种制剂的生物等效性。次要目的：评价中国健康受试者单次口服盐酸氟西汀胶囊受试制剂和参比制剂后的安全性。

[Translation]

Main objectives: 1. To study the pharmacokinetic behavior of the test formulation of fluoxetine hydrochloride capsules (20 mg/pill, Changzhou Watson Pharmaceuticals Co., Ltd.) and the reference formulation of fluoxetine hydrochloride capsules (20 mg/pill, licensee: LILLY FRANCE) in healthy Chinese subjects after a single oral administration on an empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach. 2. To study the pharmacokinetic behavior of the test formulation of fluoxetine hydrochloride capsules (20 mg/pill, Changzhou Watson Pharmaceuticals Co., Ltd.) and the reference formulation of fluoxetine hydrochloride capsules (20 mg/pill, licensee: LILLY FRANCE) in healthy Chinese subjects after a single oral administration on a empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on a empty stomach. Secondary objectives: To evaluate the safety of the test formulation and the reference formulation of fluoxetine hydrochloride capsules in healthy Chinese subjects after a single oral administration on an empty stomach.

Start Date05 Jul 2021

Sponsor / Collaborator

Changzhou Huasheng Pharmaceutical Co. Ltd.

CTR20191990 / CompletedNot Applicable

奥氮平片5 mg随机、开放、双周期、双交叉健康人体空腹及餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of olanzapine tablets 5 mg in healthy volunteers under fasting and fed conditions

主要目的：以美国礼来制药公司生产的奥氮平片(再普乐，5mg)为参比制剂，以常州华生制药有限公司生产的奥氮平片(悉敏，5mg)为受试制剂，通过单中心、随机、开放、双周期、双交叉的临床试验设计评价两种制剂在空腹及餐后给药条件下的生物等效性。次要目的：评价受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: Using olanzapine tablets (Zyprexa, 5 mg) produced by Eli Lilly and Company as the reference preparation and olanzapine tablets (Ximin, 5 mg) produced by Changzhou Watson Pharmaceuticals Co., Ltd. as the test preparation, a single-center, randomized, open, two-period, double-crossover clinical trial design was conducted to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date04 Sep 2019

Sponsor / Collaborator

Changzhou Huasheng Pharmaceutical Co. Ltd.

100 Clinical Results associated with Changzhou Huasheng Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Changzhou Huasheng Pharmaceutical Co. Ltd.

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2

Literatures (Medical) associated with Changzhou Huasheng Pharmaceutical Co. Ltd.

Huagong Shikan

Synthesis of 7-hydroxy-3,4-dihydro-2(1H)-quinolinone

Author: Wang, Shufen ; Xie, Junmin ; Xi, Xiaojin

A method for the synthesis of the title compound [i.e., 7-hydroxy-3,4-dihydro-2(1H)-quinolinone] is reported here.By substituting aluminum chloride (AlCl₃) with a small amount of boron trifluoride etherate, 7-hydroxy-3,4-dihydro-2(1H)-quinolinone was synthesized in two steps starting from 3-aminophenol.It was pure and could be used to synthesize aripiprazole [i.e., 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)quinolinone] without further purification (no data).The structure of the target compound was confirmed by elemental anal., MS, NMR, ¹³C-NMR, IR.This method is convenient, environmentally friendly and suitable for industrial scale-up production

Huagong Shikan

Synthesis and structure identification of 3-methyl-isomer in leflunomide

Author: He, Xin ; Xie, Junmin ; Xi, Xiaojin

3-Methyl-isomer (compound 2) in Leflunomide is a poisonous impurity whose quantity must be analyzed.The title product 2 with purity of 99.5% was synthesized and the structure was identified by IR, NMR, MS etc, and the product 2 could be used as the standard impurity sample to control the quality of Leflunomide.

100 Deals associated with Changzhou Huasheng Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Changzhou Huasheng Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 09 Jan 2025

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

Approved

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