Delving into the Latest Updates on Yantai Dongcheng Dayang Pharmaceutical Co. Ltd. with Synapse

Overview

主要研究目的：评估烟台东诚大洋制药有限公司生产的盐酸氨溴索分散片（规格：30mg）与Sanofi-aventis France持证，DELPHARM REIMS生产的盐酸氨溴索片（SURBRONC®EXPECTORANT ，规格：30mg）在健康受试者中空腹和餐后状态下的生物等效性。次要研究目的：观察受试制剂盐酸氨溴索分散片在健康受试者中的安全性。

[Translation]

The main purpose of the study is to evaluate the bioequivalence of Ambroxol Hydrochloride Dispersible Tablets (Specification: 30 mg) produced by Yantai Dongcheng Dayang Pharmaceutical Co., Ltd. and Ambroxol Hydrochloride Tablets (SURBRONC®EXPECTORANT, Specification: 30 mg) produced by Sanofi-aventis France and DELPHARM REIMS in healthy subjects under fasting and fed conditions. Secondary purpose of the study: to observe the safety of the test preparation Ambroxol Hydrochloride Dispersible Tablets in healthy subjects.

Start Date13 Sep 2019

Sponsor / Collaborator

Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

CTR20180998 / CompletedPhase 1

评估盐酸氨溴索分散片30mg对健康成人空腹/餐后的开放、随机、单剂量、两周期、两序列、交叉的生物等效性研究

[Translation] An open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the efficacy of ambroxol hydrochloride dispersible tablets 30 mg in healthy adults on a fasting/fed diet

主要研究目的评估烟台东诚大洋制药有限公司生产的盐酸氨溴索分散片（规格：30mg）与BOEHRINGER INGELHEIM FRANCE持证，DELPHARM REIMS生产的盐酸氨溴索片（SURBRONC® EXPECTORANT，规格：30mg）在健康受试者中空腹和餐后状态下的生物等效性试验。次要研究目的观察受试制剂盐酸氨溴索分散片在健康受试者中的安全性。

[Translation]

Main study objectives To evaluate the bioequivalence of Ambroxol Hydrochloride Dispersible Tablets (Specification: 30mg) produced by Yantai Dongcheng Dayang Pharmaceutical Co., Ltd. and Ambroxol Hydrochloride Tablets (SURBRONC® EXPECTORANT, Specification: 30mg) produced by BOEHRINGER INGELHEIM FRANCE and DELPHARM REIMS in healthy subjects under fasting and fed conditions. Secondary study objectives To observe the safety of the test preparation Ambroxol Hydrochloride Dispersible Tablets in healthy subjects.

Start Date25 Jun 2018

Sponsor / Collaborator

Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

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2

Literatures (Medical) associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

Shandong Huagong

Study on quality standard for Jiuweiqianghuo granules

Author: Li, Tingting ; Feng, Jinghui ; Li, Zhongyuan

Objective To establish the quality standard for Jiuweiqianghuo granules.Methods To discriminate Ligusticum chuanxiong, Atractylodes lancea (Thunb.) DC., Glycyrrhiza uralensis Fish. with TLC and to determine the content of Baicalin by HPLC.Results TLC is effective for discrimination of Ligusticum chuanxiong, Atractylodes lancea (Thunb.) DC., Glycyrrhiza uralensis Fish.To determine the content of Baicalin in preparation by HPLC, the calibration curve was linear within the concentration of 0.362 μg ∼ 3.62 μg (r = 0.9996), the average recovery was 100.52% with RSD0.87%.Conclusions The methods are simple, accurate, reproducible and suitable for the quality control of Jiuweiqianghuo granules.

Shandong Huagong

Study on quality standard for Zhitonghuazheng Granules

Author: Chen, Xuehui ; Feng, Jinghui

To improve the quality standard for Zhitonghuazheng Granules.The Corydalis yanhusuo W. T. Wang. was identified by TLC.Using the new method, the sample spots in the thin layer chromatogram is more clear.The method is reliable, accurate and reproducibility, and can effectively control the quality of Zhitonghuazheng Granules.

100 Deals associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 23 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

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