[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of two formulations, two sequences, four periods, and complete repeated crossover in healthy Chinese subjects

主要目的：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盐酸哌罗匹隆片（生产厂家：丽珠集团丽珠制药厂）与参比制剂盐酸哌罗匹隆片（持证商：住友ファーマ株式会社（日本住友制药有限公司），商品名：Lullan®）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。次要目的：观察受试制剂盐酸哌罗匹隆片和参比制剂盐酸哌罗匹隆片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Perospirone Hydrochloride Tablets (manufacturer: Livzon Pharmaceutical Factory of Livzon Group) and the reference preparation Perospirone Hydrochloride Tablets (licensed by Sumitomo Pharmaceuticals Co., Ltd., trade name: Lullan®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation Perospirone Hydrochloride Tablets and the reference preparation Perospirone Hydrochloride Tablets in healthy subjects.

Start Date01 May 2024

Sponsor / Collaborator

Livzon Group Livzon Pharmaceutical Factory

CTR20222399 / CompletedNot Applicable

盐酸哌罗匹隆片在健康受试者中单中心、随机、开放、两制剂、单次给药、四周期、两序列、完全重复交叉餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period, two-sequence, fully repeated crossover postprandial bioequivalence study of piropirone hydrochloride tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在餐后状态下口服受试制剂盐酸哌罗匹隆片（生产厂家：四川科瑞德制药股份有限公司）与参比制剂盐酸哌罗匹隆片（持证商：大日本住友製薬株式会社，商品名：Lullan®）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。次要目的：观察受试制剂盐酸哌罗匹隆片和参比制剂盐酸哌罗匹隆片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation Peropilone Hydrochloride Tablets (manufacturer: Sichuan Creed Pharmaceutical Co., Ltd.) and the reference preparation Peropilone Hydrochloride in the postprandial state. Pharmacokinetic behavior of Lullan tablets (licensee: Dainippon Sumitomo Co., Ltd., trade name: Lullan®) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation Peropilone Hydrochloride Tablets and the reference preparation Peropilone Hydrochloride Tablets in healthy subjects.

Start Date10 Feb 2023

Sponsor / Collaborator

Sichuan Credit Pharmaceutical Co., Ltd.

ChiCTR2200063354 / SuspendedPhase 4IIT

Perospirone hydrochloride added to SSRIs or SNRIs for major depressive disorder: a multicenter, randomised, placebo-controlled trial

Start Date12 Sep 2022

Sponsor / Collaborator

Xiangya Hospital Central South University

100 Clinical Results associated with Perospirone Hydrochloride Hydrate

100 Translational Medicine associated with Perospirone Hydrochloride Hydrate

100 Patents (Medical) associated with Perospirone Hydrochloride Hydrate

185

Literatures (Medical) associated with Perospirone Hydrochloride Hydrate

01 Sep 2024·Neuropsychopharmacology Reports

Continuous alcohol withdrawal delirium and physical illness‐associated delirium in a man brought to the emergency department after a disaster: A case report

Article

Author: Sato, Yoshiteru ; Owada, Tamaki ; Kikuchi, Kota ; Shindo, Yunosuke ; Sugawara, Norio ; Sasaki, Taro ; Hasegawa, Chie ; Kawamata, Yasushi ; Yasui‐Furukori, Norio

AbstractBackgroundRisk factors for alcohol withdrawal delirium include heavy drinking, prior alcohol withdrawal delirium or convulsions, nondrug sedative use, and a history of tachycardia, withdrawal, and infections.Case PresentationA 76‐year‐old man with a history of heavy drinking and type 2 diabetes was hospitalized for hypothermia, rhabdomyolysis, and acute renal failure after a typhoon. He developed alcohol withdrawal symptoms 24 h after his last drink, leading to severe withdrawal delirium characterized by restlessness, delusions, and altered consciousness. Treatment included lorazepam, in addition to comprehensive care for his physical condition. His condition fluctuated, especially at night, with his psychiatric symptoms exacerbated by his physical illnesses, suggesting delirium due to the coexistence of severe and multiple physical illnesses. After 44 days, following substantial improvements in both mental and physical health with perospirone, the patient was discharged.ConclusionThis case emphasizes the need for multidisciplinary collaboration in the treatment of such patients, especially during disasters, and the importance of long‐term monitoring for elderly patients with alcohol dependence syndrome after a disaster.

01 Jun 2024·Molecular Diversity

Exploration of interaction interface of TRKβ/BDNF through fingerprint analysis to disinter potential agonists

Article

Author: Satish, Kshreeraja S ; Hemasree, G N S ; Burri, Raghunadha R ; Murthy, T P Krishna ; Rajalekshmi, Saraswathy Ganesan

Tyrosine Kinase beta (TRKβ), is a type I membrane receptor which plays a major role in various signalling pathways. TRKβ was found to be upregulated in various cancers and contrastingly downregulated in various neurodegenerative disorders. Hitherto, contemporary drug research is oriented towards discovery of TRKβ inhibitors, thus neglecting the development of TRKβ agonists. This research is aimed at identifying FDA approved drugs exhibiting repurposable potential as TRKβ agonists by mapping them with fingerprints of the BDNF/TRKβ interaction interface. Initially, crucial interacting residues were retrieved and a receptor grid was generated around it. TRKβ agonists were retrieved from literature search and a drug library was created for each agonist based on its structural and side effect similarities. Subsequently, molecular docking and dynamics were performed for each library to identify the drugs possessing affinity towards the binding pocket of TRKβ. The study revealed molecular interactions of Perospirone, Droperidol, Urapidil, and Clobenzorex with the crucial amino acids lining the active binding pocket of TRKβ. Subsequent network pharmacological analysis of the above drugs revealed their interactions with key proteins involved in neurotransmitter signalling pathways. Clobenzorex displayed high stability in dynamics simulation and therefore this drug is recommended for further experimental evaluations to attain better mechanistic insights and predict its implications in correcting neuropathological aberrations. This study's focus on the interaction interface between TRKβ and BDNF, combined with the utilization of fingerprint analysis for drug repurposing, contributes to our understanding of neurotrophic signalling and holds potential for identifying new therapeutic options for neurological disorders.

01 Jun 2024·Neuropsychopharmacology Reports

The effective perospirone augmentation with clonazepam for treatment‐resistant burning mouth syndrome: A case report

Article

Author: Tominaga, Risa ; Kimura, Yasuyuki ; Nayanar, Gayatri ; Takao, Chihiro ; Toyofuku, Akira ; Nagamine, Takahiko ; Watanabe, Motoko ; Maeda, Chizuko ; Tu, Trang Thi Huyen

AbstractBurning mouth syndrome (BMS) is characterized by burning sensations in the oral region without corresponding abnormalities and is often accompanied by uncomfortable sensations. Herein, we present cases of BMS in which the remaining uncomfortable sensations improved with perospirone augmentation with clonazepam. Case 1: A 61‐year‐old man complained of a burning pain in his tongue, a sensation of dryness and discomfort as if his tongue was sticking to a palatal plate. With the diagnosis of BMS, psychopharmacotherapy was initiated with amitriptyline. At the dose of amitriptyline 50 mg, the pain lessened but uncomfortable sensations persisted. Further attempts to alleviate symptoms by combining aripiprazole with amitriptyline, aripiprazole with mirtazapine, or aripiprazole with clonazepam were limited; however, nearly all symptoms were relieved by a combination of perospirone 8.0 mg with clonazepam 1.5 mg. Case 2: A 51‐year‐old woman complained of a burning sensation along with oral dryness and crumb‐like feeling on her tongue. She was diagnosed with BMS and began treatment with amitriptyline. Her burning sensation improved at the dose of 25 mg, but uncomfortable sensations persisted. Augmentation of amitriptyline with aripiprazole, aripiprazole either with valproate, mirtazapine, or clonazepam failed to produce a significant improvement. However, a regimen of perospirone 6.0 mg and clonazepam 1.5 mg relieved the crumb‐like sensation and pain and culminated in a stabilized condition. The reported cases suggested that multiple approaches targeting the dopaminergic circuit in basal ganglia involving the serotoninergic and GABA systems, through the administration of perospirone with clonazepam is an effective adjunctive treatment for the remaining uncomfortable sensations in patients with BMS.

100 Deals associated with Perospirone Hydrochloride Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D02372	Perospirone Hydrochloride Hydrate	N05	DB08922

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Indication	Country/Location	Organization	Date
Schizophrenia	JP	Sumitomo Pharma Co., Ltd.	22 Dec 2000

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