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

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Digestive System Disorders

Small molecule drug

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Top 5 Drug Type	Count

Small molecule drug	1

主要研究目的健康受试者空腹或餐后状态下，单次口服山西新宝源制药有限公司生产的受试制剂硝苯地平控释片（规格：90mg）或Pfizer Laboratories Div Pfizer Inc生产的参比制剂硝苯地平控释片（商品名：PROCARDIA XL®；规格：90mg），分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。次要研究目的考察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main study objectives Healthy subjects were given a single oral dose of the test preparation nifedipine controlled-release tablets (specification: 90 mg) produced by Shanxi Xinbaoyuan Pharmaceutical Co., Ltd. or the reference preparation nifedipine controlled-release tablets (trade name: PROCARDIA XL®; specification: 90 mg) produced by Pfizer Laboratories Div Pfizer Inc. in the fasting or postprandial state to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects, respectively, and to evaluate the bioequivalence of the two preparations. Secondary study objectives Investigate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date15 Feb 2022

Sponsor / Collaborator

Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

CTR20200021 / CompletedPhase 1

胶体果胶铋颗粒与枸橼酸铋钾片、枸橼酸铋钾颗粒在健康人群中单次口服给药的药代动力学比较试验方案

[Translation] Comparative study on the pharmacokinetic characteristics of colloidal pectin bismuth granules, bismuth potassium citrate tablets, and bismuth potassium citrate granules after single oral administration in healthy subjects

1. 研究健康受试者空腹单次口服胶体果胶铋颗粒、枸橼酸铋钾片和枸橼酸铋钾颗粒的药代动力学特征 2. 以持证商为 TORA LABORATORIES.S.L 的枸橼酸铋钾片（gastrodenol）和丽珠集团丽珠制药厂生产的枸橼酸铋钾颗粒（丽珠得乐）为参比制剂，以胶体果胶铋颗粒为受试制剂，比较参比制剂和受试制剂空腹单次给药后的药动学参数Cmax、AUC0-t 和AUC0-∞，评价受试制剂的安全性

[Translation]

1. To study the pharmacokinetic characteristics of colloidal pectin bismuth granules, bismuth potassium citrate tablets and bismuth potassium citrate granules in healthy subjects after a single oral fasting dose. 2. Using bismuth potassium citrate tablets (gastrodenol) from TORA LABORATORIES.S.L and bismuth potassium citrate granules (Livzon Dele) produced by Livzon Pharmaceutical Factory of Livzon Group as reference preparations and colloidal pectin bismuth granules as test preparations, the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the reference preparations and the test preparations after a single fasting dose were compared, and the safety of the test preparations was evaluated.

Start Date09 Jan 2020

Sponsor / Collaborator

Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

CTR20200022 / CompletedPhase 1

胶体果胶铋胶囊与枸橼酸铋钾片、枸橼酸铋钾颗粒在健康人群中单次口服给药的药代动力学比较试验方案

[Translation] Comparative study on the pharmacokinetic characteristics of colloidal pectin bismuth capsules, bismuth potassium citrate tablets, and bismuth potassium citrate granules after single oral administration in healthy subjects

1. 研究健康受试者空腹单次口服胶体果胶铋颗粒、枸橼酸铋钾片和枸橼酸铋钾颗粒的药代动力学特征 2. 以持证商为 TORA LABORATORIES.S.L 的枸橼酸铋钾片（gastrodenol）和丽珠集团丽珠制药厂生产的枸橼酸铋钾颗粒（丽珠得乐）为参比制剂，以胶体果胶铋颗粒为受试制剂，比较参比制剂和受试制剂空腹单次给药后的药动学参数Cmax、AUC0-t 和AUC0-∞，评价受试制剂的安全性

[Translation]

1. To study the pharmacokinetic characteristics of colloidal pectin bismuth granules, bismuth potassium citrate tablets and bismuth potassium citrate granules in healthy subjects after a single oral fasting dose. 2. Using bismuth potassium citrate tablets (gastrodenol) from TORA LABORATORIES.S.L and bismuth potassium citrate granules (Livzon Dele) produced by Livzon Pharmaceutical Factory of Livzon Group as reference preparations and colloidal pectin bismuth granules as test preparations, the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the reference preparations and the test preparations after a single fasting dose were compared, and the safety of the test preparations was evaluated.

Start Date09 Jan 2020

Sponsor / Collaborator

Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

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

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100 Deals associated with Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 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

1

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