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

Overview

本试验旨在研究单次空腹和餐后口服广西厚德大健康产业股份有限公司研制、生产的非洛地平琥珀酸美托洛尔缓释片（5/47.5 mg）的药代动力学特征；以阿斯利康制药有限公司生产的非洛地平琥珀酸美托洛尔缓释片（Logimax ® ，5/47.5mg）为参比制剂，比较两制剂中药动学参数 C max 、AUC 0-t 、AUC 0-∞ ，评价两制剂的人体生物等效性。

[Translation]

This study aims to study the pharmacokinetic characteristics of single fasting and postprandial oral administration of felodipine metoprolol succinate sustained-release tablets (5/47.5 mg) developed and produced by Guangxi Houde Health Industry Co., Ltd.; using felodipine metoprolol succinate sustained-release tablets (Logimax ® , 5/47.5 mg) produced by AstraZeneca Pharmaceuticals Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters C max , AUC 0-t , and AUC 0-∞ of the two preparations, and evaluate the human bioequivalence of the two preparations.

Start Date-

Sponsor / Collaborator

Guangxi Boke Pharmaceutical Co., Ltd.

CTR20190910

/ CompletedNot Applicable

采用单剂量口服、随机、开放、两制剂、两周期、两序列交叉试验设计方法进行琥珀酸美托洛尔缓释片BE试验

[Translation] A single-dose oral, randomized, open-label, two-dose, two-period, two-sequence crossover trial design was used to conduct a BE trial of metoprolol succinate sustained-release tablets.

研究广西厚德大健康产业股份有限公司生产的琥珀酸美托洛尔缓释片是否与阿斯利康制药有限公司生产的琥珀酸美托洛尔缓释片(倍他乐克，Betaloc ZOK®）生物等效。

[Translation]

To investigate whether metoprolol succinate sustained-release tablets produced by Guangxi Houde Healthcare Industry Co., Ltd. are bioequivalent to metoprolol succinate sustained-release tablets (Betaloc ZOK®) produced by AstraZeneca Pharmaceuticals Ltd.

Start Date31 Dec 2019

Sponsor / Collaborator

Guangxi Boke Pharmaceutical Co., Ltd.

CTR20160865

/ CompletedPhase 1

采用单剂量口服、随机、开放、双周期交叉试验设计方法进行琥珀酸美托洛尔缓释片人体生物等效性试验

[Translation] Bioequivalence study of metoprolol succinate sustained-release tablets in humans using a single-dose oral, randomized, open-label, two-period crossover trial design

研究受试者分别在空腹和餐后状态下单次口服广西厚德大健康产业股份有限公司（原广西博科药业有限公司）生产的琥珀酸美托洛尔缓释片（47.5mg）与阿斯利康制药有限公司琥珀酸美托洛尔缓释片(贝他乐克ZOK？)的相关药代动力学参数，评价两制剂的生物等效性。

[Translation]

The relevant pharmacokinetic parameters of metoprolol succinate sustained-release tablets (47.5 mg) produced by Guangxi Houde Health Industry Co., Ltd. (formerly Guangxi Boke Pharmaceutical Co., Ltd.) and metoprolol succinate sustained-release tablets (Betaloc ZOK?) produced by AstraZeneca Pharmaceuticals Co., Ltd. were compared with those of the study subjects after a single oral administration in the fasting and postprandial states, and the bioequivalence of the two preparations was evaluated.

Start Date07 Jul 2017

Sponsor / Collaborator

Guangxi Boke Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guangxi Boke Pharmaceutical Co., Ltd.

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

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100 Deals associated with Guangxi Boke Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Guangxi Boke Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 29 Apr 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

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