[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of difenidol hydrochloride tablets in healthy subjects on fasting and fed diet

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

100 Translational Medicine associated with Diphenidol Hydrochloride

100 Patents (Medical) associated with Diphenidol Hydrochloride

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

Chronic neuropathic pain is an increasingly prevalent societal issue that responds poorly to existing therapeutic strategies. The α9α10 nicotinic acetylcholine receptor (nAChR) has emerged as a potential target to treat neuropathic pain. However, challenges in expressing functional α9α10 nAChRs in mammalian cell lines have slowed the discovery of α9α10 ligands and studies into the relationship between α9α10 nAChRs and neuropathic pain. Here, we develop a cell line in the HEK293 background that stably expresses functional α9α10 nAChRs. By also developing cell lines expressing only α9 and α10 subunits, we identify distinct receptor pharmacology between homomeric α9 or α10 and heteromeric α9α10 nAChRs. Moreover, we demonstrate that incubation with nAChR ligands differentially regulates the expression of α9- or α10-containing nAChRs, suggesting a possible mechanism by which ligands may modify receptor composition and trafficking in α9- and α10-expressing cells. We then apply our α9α10 cell line in a screen of FDA-approved and investigational drugs to identify α9α10 ligands that provide new tools to probe α9α10 nAChR function. We demonstrate that one compound from this screen, diphenidol, possesses antinociceptive activity in a murine model of neuropathic pain. These results expand our understanding of α9α10 receptor pharmacology and provide new starting points for developing efficacious neuropathic pain treatments.

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, 冰 ; 高, 日红 ; 郑, 立新 ; 王, 新宙

25 Aug 2023·Fa yi xue za zhi

Retrospective Analysis of Death Cases of Oral Diphenidol Hydrochloride Poisoning.

Article

Author: Yang, Yu ; Dong, Yu-You ; Ma, Jian-Long ; Ye, Xue-Song ; Shi, Qi-Qiang ; Lei, Fan-Zhang

OBJECTIVESTo explore the characteristics of postmortem examination, chemical examination and scene investigation of deaths caused by oral diphenidol hydrochloride poisoning, and so as to provide a reference for proper settlement and prevention of such deaths.METHODSThe data of 22 deaths caused by oral diphenidol hydrochloride poisoning in a city from January 2018 to August 2020 were collected, including case details, scene investigations, autopsies, chemical examinations and digital evidence. Thirty-one cases of deaths caused by oral diphenidol hydrochloride poisoning reported in previous literature were also collected.RESULTSIn the 53 oral diphenidol hydrochloride poisoning death cases, 50 cases were suicide, 2 cases were accidental, while 1 case was undetermined. Fifty-two cases were found in the medical records or crime scene investigation reports with doses ranging from 775 mg to 12 500 mg, and 23 deceased were detected with postmortem blood concentrations ranging from 2.71 mg/L to 83.1 mg/L. Clinical symptoms were recorded in 6 patients, including conscious disturbance and convulsion. Among the 45 cases which were performed with external examination, 23 cases autopsied.CONCLUSIONSMost of the deceased of oral diphenidol hydrochloride poisoning were suicide. No significant correlation was found between dose and blood concentration through the retrospective analysis of cases.

100 Deals associated with Diphenidol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01318	-	A04A	DB01231

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Indication	Country/Location	Organization	Date
Dizziness	JP	Nippon Shinyaku Co., Ltd.	01 Apr 1974

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