Delving into the Latest Updates on Sichuan Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Nervous System Diseases

Congenital Disorders

Immune System Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

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Disease Domain	Count

Endocrinology and Metabolic Disease	1
Infectious Diseases	1
Immune System Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

Cu(Copper)	1
PBPs(Bacterial penicillin-binding protein)	1

主要研究目的：按有关生物等效性试验的规定，选择Patheon Inc生产的磷酸特地唑胺片（商品名：SIVEXTRO®，规格：200mg）为参比制剂，对四川制药制剂有限公司生产的受试制剂磷酸特地唑胺片（规格：200mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂在健康受试者体内中的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂磷酸特地唑胺片（规格：200mg）和参比制剂磷酸特地唑胺片（商品名：SIVEXTRO®，规格：200mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, tedizolid phosphate tablets (trade name: SIVEXTRO®, specification: 200 mg) produced by Patheon Inc were selected as the reference preparation, and the test preparation tedizolid phosphate tablets (specification: 200 mg) produced by Sichuan Pharmaceutical Preparation Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the test preparation in healthy subjects were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation tedizolid phosphate tablets (specification: 200 mg) and the reference preparation tedizolid phosphate tablets (trade name: SIVEXTRO®, specification: 200 mg) by healthy volunteers.

Start Date16 Jul 2022

Sponsor / Collaborator

Sichuan Pharmaceutical Co., Ltd.

CTR20212993 / CompletedNot Applicable

健康人体在单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉餐后状态下给药的生物等效性研究。

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study in healthy humans administered under fed conditions.

本试验旨在研究餐后状态下口服单剂量磷酸西格列汀片（100 mg）四川制药制剂有限公司研制、生产的受试制剂与磷酸西格列汀片（100 mg）Merck Sharp & Dohme Ltd.生产的参比制剂，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，并观察两制剂的安全性。

[Translation]

The purpose of this study was to study the oral single-dose sitagliptin phosphate tablets (100 mg) developed and produced by Sichuan Pharmaceutical Preparation Co., Ltd. and the reference preparation of sitagliptin phosphate tablets (100 mg) produced by Merck Sharp & Dohme Ltd. in the postprandial state, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the bioequivalence of the two preparations in humans, and to observe the safety of the two preparations.

Start Date20 Dec 2021

Sponsor / Collaborator

Sichuan Pharmaceutical Co., Ltd.

CTR20212991 / CompletedNot Applicable

健康人体在单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉空腹状态下给药的生物等效性研究。

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-cycle, two-sequence, double-crossover bioequivalence study was conducted in healthy subjects under fasting conditions.

本试验旨在研究空腹状态下口服单剂量磷酸西格列汀片（100 mg）四川制药制剂有限公司研制、生产的受试制剂与磷酸西格列汀片（100 mg）Merck Sharp & Dohme Ltd.生产的参比制剂，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，并观察两制剂的安全性。

[Translation]

The purpose of this study was to study the oral administration of a single dose of sitagliptin phosphate tablets (100 mg) developed and produced by Sichuan Pharmaceutical Preparation Co., Ltd. in the fasting state and the reference preparation of sitagliptin phosphate tablets (100 mg) produced by Merck Sharp & Dohme Ltd., to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the bioequivalence of the two preparations in humans, and to observe the safety of the two preparations.

Start Date18 Dec 2021

Sponsor / Collaborator

Sichuan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Sichuan Pharmaceutical Co., Ltd.

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

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1

Literatures (Medical) associated with Sichuan Pharmaceutical Co., Ltd.

Zhongguo Yaoye

Improvement of crystallization of sulbactam sodium

Author: Jiang, Haowei

The purity and yield of sulbactam sodium were improved by using azeotropic distillation crystallizationThe satisfactory results were obtained by mass tests with yield of 98% and purity of 92%.The improved technol. is feasible.

100 Deals associated with Sichuan Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Sichuan Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 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

Approved

2

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