Delving into the Latest Updates on Hebei Medical University Pharmaceutical Factory with Synapse

Overview

Tags

Immune System Diseases

Infectious Diseases

Urogenital Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

RT(Viral reverse transcriptase)	1

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂硝苯地平缓释片(生产厂家：乐声药业石家庄有限公司)与参比制剂硝苯地平缓释片(持证商：Bayer Hi spani a, S. L.商品名：Adalat?retad)后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂硝苯地平缓释片和参比制剂硝苯地平缓释片在健康受试者中的安全性。

[Translation]

The pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behavior of the test preparation Nifedipine Sustained Release Tablets (manufacturer: Lesheng Pharmaceutical Shijiazhuang Co., Ltd.) and the reference preparation Nifedipine Sustained Release Tablets (certificate holder: Bayer Hi spani a, S. L. trade name: Adalat?retad) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. The safety of the test preparation Nifedipine Sustained Release Tablets and the reference preparation Nifedipine Sustained Release Tablets in healthy subjects was observed.

Start Date09 Oct 2023

Sponsor / Collaborator

Hebei Medical University Pharmaceutical Factory

CTR20192173 / Completed

硝苯地平缓释片（Ⅱ）健康受试者单中心随机开放两制剂单次给药两周期双交叉高脂餐后人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-cycle, double-crossover bioequivalence study of nifedipine sustained-release tablets (Ⅱ) in healthy subjects after a high-fat meal with two single-dose formulations

以河北医科大学制药厂的硝苯地平缓释片（Ⅱ）（规格：20mg/片）为受试制剂，以バイエル薬品株式会社（日本拜耳药品株式会社）的硝苯地平缓释片（商品名：Adalat®-L20，规格：20mg/片）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。

[Translation]

Nifedipine sustained-release tablets (II) (specification: 20 mg/tablet) produced by Hebei Medical University Pharmaceutical Factory was used as the test preparation, and nifedipine sustained-release tablets (trade name: Adalat®-L20, specification: 20 mg/tablet) produced by Bayer Pharmaceutical Co., Ltd. (Japan Bayer Pharmaceutical Co., Ltd.) was used as the reference preparation. According to the relevant provisions of bioequivalence test, the bioequivalence of the two preparations in healthy volunteers was investigated.

Start Date15 Dec 2019

Sponsor / Collaborator

Hebei Medical University Pharmaceutical Factory

CTR20192104 / Completed

硝苯地平缓释片（Ⅱ）在健康受试者中单中心随机开放两制剂单次给药两周期双交叉空腹人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, double-crossover fasting bioequivalence study of nifedipine sustained-release tablets (Ⅱ) in healthy subjects

以河北医科大学制药厂的硝苯地平缓释片（Ⅱ）（规格：20mg/片）为受试制剂，以バイエル薬品株式会社（日本拜耳药品株式会社）的硝苯地平缓释片（商品名：Adalat®-L20，规格：20mg/片）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。

[Translation]

Nifedipine sustained-release tablets (II) (specification: 20 mg/tablet) produced by Hebei Medical University Pharmaceutical Factory was used as the test preparation, and nifedipine sustained-release tablets (trade name: Adalat®-L20, specification: 20 mg/tablet) produced by Bayer Pharmaceutical Co., Ltd. (Japan Bayer Pharmaceutical Co., Ltd.) was used as the reference preparation. According to the relevant provisions of bioequivalence test, the bioequivalence of the two preparations in healthy volunteers was investigated.

Start Date02 Nov 2019

Sponsor / Collaborator

Hebei Medical University Pharmaceutical Factory

100 Clinical Results associated with Hebei Medical University Pharmaceutical Factory

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0 Patents (Medical) associated with Hebei Medical University Pharmaceutical Factory

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100 Deals associated with Hebei Medical University Pharmaceutical Factory

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100 Translational Medicine associated with Hebei Medical University Pharmaceutical Factory

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Pipeline

Pipeline Snapshot as of 22 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

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