Delving into the Latest Updates on Diphenidol Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

alpha,alpha-Diphenyl-1-piperidinebutanol, Difenidol Hydrochloride, Difenidol hydrochloride (JP17)

+ [19]

Target

ORAI1

Mechanism

ORAI1 inhibitors(Calcium release-activated calcium channel protein 1 inhibitors)

Therapeutic Areas

Nervous System Diseases

Active Indication

Dizziness

Inactive Indication

NauseaVertigo

Originator Organization

GSK Plc

Active Organization

Nippon Shinyaku Co., Ltd.

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

US (05 Apr 1967),

NauseaVertigo

Regulation-

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Structure

Molecular FormulaC21H28ClNO

InChIKeyAVZIYZHXZAYGJS-UHFFFAOYSA-N

CAS Registry3254-89-5

主要研究目的：以江苏亚邦爱普森药业有限公司研制的盐酸地芬尼多片（规格：25 mg）为受试制剂，按生物等效性研究的有关规定，与日本新药株式会社生产的盐酸地芬尼多片（参比制剂，商品名：Cephadol®，规格：25 mg）对比在健康人体内的药代动力学特征，考察两制剂的人体生物等效性。次要研究目的：考察盐酸地芬尼多片受试制剂（规格：25 mg）和参比制剂（商品名：Cephadol ®，规格：25 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study: Using the difenidol hydrochloride tablets (specification: 25 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence study, the pharmacokinetic characteristics of the difenidol hydrochloride tablets (reference preparation, trade name: Cephadol®, specification: 25 mg) produced by Japan Shinyaku Co., Ltd. were compared in healthy humans to investigate the bioequivalence of the two preparations. Secondary purpose of the study: To investigate the safety of the test preparation of difenidol hydrochloride tablets (specification: 25 mg) and the reference preparation (trade name: Cephadol®, specification: 25 mg) in healthy subjects.

Start Date12 Oct 2022

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

CTR20213278 / CompletedPhase 1

盐酸地芬尼多片随机、开放、单剂量、两周期、两序列、交叉、单次给药试验设计在健康人体空腹和餐后状态下生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover, single-dose study was conducted to conduct a bioequivalence study of difenidol hydrochloride tablets in healthy humans under fasting and fed conditions.

健康受试者在空腹和餐后状态下口服江苏亚邦爱普森药业有限公司生产的受试制剂盐酸地芬尼多片与日本新薬株式会社生产的参比制剂盐酸地芬尼多片后，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

The bioequivalence of the test preparation, difenidol hydrochloride tablets produced by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. and the reference preparation, difenidol hydrochloride tablets produced by Japan Shinyaku Co., Ltd., was evaluated in healthy subjects after oral administration in the fasting and fed states.

Start Date16 Dec 2021

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

CTR20191148 / CompletedPhase 1

盐酸地芬尼多片随机、开放、单剂量、两制剂、两周期、交叉设计在健康人体空腹和餐后状态下生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, crossover-design bioequivalence study of difenidol hydrochloride tablets in healthy volunteers under fasting and fed conditions

健康受试者在空腹和餐后状态下口服仁和堂药业有限公司生产的受试制剂盐酸地芬尼多片与Nippon Shinyaku Co.,Ltd.生产的参比制剂盐酸地芬尼多片后，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

The bioequivalence of the test preparation, difenidol hydrochloride tablets produced by Renhetang Pharmaceutical Co., Ltd. and the reference preparation, difenidol hydrochloride tablets produced by Nippon Shinyaku Co., Ltd., was evaluated in healthy subjects after oral administration in the fasting and fed states.

Start Date01 Jul 2019

Sponsor / Collaborator

Shandong Province Renhetang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Diphenidol Hydrochloride

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100 Translational Medicine associated with Diphenidol Hydrochloride

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100 Patents (Medical) associated with Diphenidol Hydrochloride

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96

Literatures (Medical) associated with Diphenidol Hydrochloride

15 Nov 2024·ACS Chemical Biology

Discovery of Antinociceptive α9α10 Nicotinic Acetylcholine Receptor Antagonists by Stable Receptor Expression

Article

Author: Harris, Lauren M. ; Gunasekara, Hirushi ; Peters, Christian J. ; Kremiller, Kyle M. ; Hu, Ying S. ; Kashyap, Yavnika ; Wang, Zaijie J. ; Riley, Andrew P. ; Kulkarni, Gauri C. ; Nguyen, Angela ; Ilktach, Giokdjen ; Ondrus, Alison E.

01 Sep 2024·JOURNAL OF CHROMATOGRAPHY A

Investigation of biodistribution by liquid-phase microextraction: Using a fatal diphenidol poisoning case

Article

Author: Xiong, Jianhua ; Huang, Chuixiu ; Zhang, Xinwei ; Zhou, Yiwu ; Zhao, Shuquan ; Ma, Longda ; Tian, Yu

25 Oct 2023·Fa yi xue za zhi

[Death caused by high-dose difenidol hydrochloride combined with ethanol and potassium chloride poisoning： A case report].

Article

Author: 王, 新宙 ; 高, 日红 ; 王, 冰 ; 郑, 立新

100 Deals associated with Diphenidol Hydrochloride

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