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

Overview

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design of oseltamivir phosphate dry suspension in healthy Chinese subjects was divided into two parts: fasting administration and postprandial administration human bioequivalence study

本试验旨在研究单次空腹和餐后口服北京斯利安药业有限公司生产的磷酸奥司他韦干混悬剂〔6 mg/mL（以奥司他韦计）〕的药代动力学特征；以Roche Pharma AG生产的磷酸奥司他韦干混悬剂〔TAMIFLU®，6 mg/mL（以奥司他韦计）〕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]

The purpose of this study was to study the pharmacokinetic characteristics of a single fasting and postprandial oral administration of oseltamivir phosphate dry suspension [6 mg/mL (as oseltamivir)] produced by Beijing Silian Pharmaceutical Co., Ltd.; using oseltamivir phosphate dry suspension [TAMIFLU®, 6 mg/mL (as oseltamivir)] produced by Roche Pharma AG 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 Date-

Sponsor / Collaborator

Beijing Silian Pharmaceutical Co., Ltd.

CTR20243090 / RecruitingNot Applicable

艾地骨化醇软胶囊（0.75μg）在健康受试者中空腹和餐后状态下单中心、随机、开放、单剂量、两制剂、两周期、两序列、自身交叉的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, self-crossover bioequivalence study of idecalciferol soft capsules (0.75 μg) in healthy subjects under fasting and fed conditions

主要目的：以北京斯利安药业有限公司提供的艾地骨化醇软胶囊（规格：0.75μg）为受试制剂，原研Chugai Pharmaceutical Co.,Ltd持证的艾地骨化醇软胶囊（规格：0.75μg，商品名：Edirol®）为参比制剂，在空腹和餐后状态下评价受试制剂同参比制剂的生物等效性。次要目的：观察空腹和餐后状态下受试制剂艾地骨化醇软胶囊和参比制剂艾地骨化醇软胶囊（Edirol®）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation with the reference preparation under fasting and postprandial conditions, using the edicalcitol soft capsules (specification: 0.75μg) provided by Beijing Silian Pharmaceutical Co., Ltd. as the test preparation and the edicalcitol soft capsules (specification: 0.75μg, trade name: Edirol®) certified by Chugai Pharmaceutical Co., Ltd. as the reference preparation. Secondary objective: To observe the safety of the test preparation edicalcitol soft capsules and the reference preparation edicalcitol soft capsules (Edirol®) in healthy subjects under fasting and postprandial conditions.

Start Date13 Aug 2024

Sponsor / Collaborator

Beijing Silian Pharmaceutical Co., Ltd.

CTR20241221 / CompletedNot Applicable

富马酸伏诺拉生片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral, two-formulation, two-period, crossover bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects

主要目的：以北京斯利安药业有限公司提供的富马酸伏诺拉生片（20 mg）为受试制剂（T），以Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片（商品名：沃克®/Vocinti®，20 mg）为参比制剂（R），评估健康受试者在空腹及餐后状态下单次给药受试制剂和参比制剂的药代动力学特征，评价两种制剂的人体生物等效性。次要目的：考察健康受试者口服受试制剂和参比制剂的安全性。

[Translation]

Main purpose: Using vonoprazan fumarate tablets (20 mg) provided by Beijing Silian Pharmaceutical Co., Ltd. as the test preparation (T), and vonoprazan fumarate tablets (trade name: Walker®/Vocinti®, 20 mg) certified by Takeda Pharmaceutical Company Limited as the reference preparation (R), the pharmacokinetic characteristics of the test preparation and the reference preparation in healthy subjects in the fasting and postprandial state were evaluated, and the bioequivalence of the two preparations was evaluated. Secondary purpose: Investigate the safety of the test preparation and the reference preparation in oral administration to healthy subjects.

Start Date22 May 2024

Sponsor / Collaborator

Beijing Silian Pharmaceutical Co., Ltd.

100 Clinical Results associated with Beijing Silian Pharmaceutical Co., Ltd.

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

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100 Deals associated with Beijing Silian Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Beijing Silian Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 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

IND Approval

1

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