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

Overview

Basic Info

Introduction

Shandong Phoenix Pharmaceutical Co., Ltd., based in Shandong, China, is a distinguished manufacturing firm specializing in the pharmaceutical sector. It is explicitly known for its remarkable production and distribution of traditional Chinese medicines (TCMs). The company aims to keep the thousands of years old cultural healing identity alive while meeting international standards. Phoenix Pharmaceutical ensures all manufactured products pass through rigorous quality control to maintain the efficacy, safety, and purity of each medication produced. This makes it a trusted and valued entity in the healthcare sector.

Tags

Nervous System Diseases

Endocrinology and Metabolic Disease

Cardiovascular Diseases

Herbal medicine

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

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No Data

Disease Domain	Count

Endocrinology and Metabolic Disease	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Herbal medicine	2

主要目的：本研究以山东凤凰制药股份有限公司生产的马来酸阿伐曲泊帕片（规格：20mg）为受试制剂，Kawashima Plant, Eisai Co., Ltd.生产的马来酸阿伐曲泊帕片（商品名：苏可欣®，规格：20mg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂和参比制剂在健康受试者体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: This study used Avatrombopag Maleate Tablets (Specification: 20 mg) produced by Shandong Phoenix Pharmaceutical Co., Ltd. as the test preparation and Avatrombopag Maleate Tablets (Trade name: Sukoxin®, Specification: 20 mg) produced by Kawashima Plant, Eisai Co., Ltd. as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date14 Mar 2023

Sponsor / Collaborator

Shandong Phoenix Pharmaceutical Co., Ltd.

CTR20221376 / CompletedNot Applicable

卡格列净片在健康受试者中的单中心的随机、开放、单剂量、双周期、双交叉、空腹/餐后试验。

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover, fasting/fed trial of canagliflozin tablets in healthy subjects.

中国健康受试者空腹/餐后状态下，口服单剂量卡格列净片（CanagliflozinTablets，受试制剂T，山东凤凰制药股份有限公司生产，规格：100 mg/片）与卡格列净片（Canagliflozin Tablets，参比制剂R，Janssen-Cilag InternationalNV持证，Janssen-Cilag S.p.A.生产，商品名：INVOKANA®/怡可安®，规格：100 mg/片）进行生物等效研究，研究受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。观察受试制剂卡格列净片和参比制剂卡格列净片（INVOKANA®/怡可安®）在健康受试者中的安全性。

[Translation]

A bioequivalence study was conducted on Chinese healthy subjects in the fasting/postprandial state by taking a single oral dose of canagliflozin tablets (Canagliflozin Tablets, test preparation T, produced by Shandong Phoenix Pharmaceutical Co., Ltd., specification: 100 mg/tablet) and canagliflozin tablets (Canagliflozin Tablets, reference preparation R, licensed by Janssen-Cilag International NV, produced by Janssen-Cilag S.p.A., trade name: INVOKANA®/Yi Ke An®, specification: 100 mg/tablet) to study the absorption rate and degree of the test preparation and the reference preparation in the human body and evaluate whether the test preparation and the reference preparation are bioequivalent. Observe the safety of the test preparation canagliflozin tablets and the reference preparation canagliflozin tablets (INVOKANA®/Yi Ke An®) in healthy subjects.

Start Date24 May 2022

Sponsor / Collaborator

Shandong Phoenix Pharmaceutical Co., Ltd.

CTR20211521 / CompletedNot Applicable

替格瑞洛片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后条件下单次给药、两制剂、两序列、两周期、双交叉的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of ticagrelor tablets in healthy adult Chinese subjects under fasting and fed conditions

主要研究目的：考察空腹/餐后条件下单次口服90mg受试制剂替格瑞洛片（规格：90mg/片，山东凤凰制药股份有限公司生产）与参比制剂替格瑞洛片（商品名：BRILINTA®，规格：90mg/片，ASTRAZENECA AB生产）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态分别口服两种制剂的生物等效性。次要研究目的：评价受试制剂和参比制剂空腹/餐后条件下单次口服90mg在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the pharmacokinetic characteristics of a single oral dose of 90 mg of the test preparation Ticagrelor Tablets (Specification: 90 mg/tablet, produced by Shandong Phoenix Pharmaceutical Co., Ltd.) and the reference preparation Ticagrelor Tablets (trade name: BRILINTA®, Specification: 90 mg/tablet, produced by ASTRAZENECA AB) in healthy adult Chinese subjects under fasting/fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally in fasting and fed states. Secondary study objectives: To evaluate the safety of a single oral dose of 90 mg of the test preparation and the reference preparation in healthy adult Chinese subjects under fasting/fed conditions.

Start Date29 Jul 2021

Sponsor / Collaborator

Shandong Phoenix Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shandong Phoenix Pharmaceutical Co., Ltd.

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

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100 Deals associated with Shandong Phoenix Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shandong Phoenix Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 17 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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