[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of piribedil sustained-release tablets (50 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择Les Laboratoires Servier为持证商的吡贝地尔缓释片（商品名：泰舒达，规格：50mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂吡贝地尔缓释片（规格：50mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂吡贝地尔缓释片（规格：50mg）和参比制剂吡贝地尔缓释片（商品名：泰舒达，规格：50mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Piribedil sustained-release tablets (trade name: Taishuda, specification: 50 mg) with Les Laboratoires Servier as the licensee were selected as the reference preparation, and the test preparation Piribedil sustained-release tablets (specification: 50 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Piribedil sustained-release tablets (specification: 50 mg) and the reference preparation Piribedil sustained-release tablets (trade name: Taishuda, specification: 50 mg) in healthy subjects.

Start Date06 Sep 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242616 / Active, not recruitingNot Applicable

吡贝地尔缓释片人体生物等效性研究

[Translation] Study on the bioequivalence of piribedil sustained-release tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服重庆华森制药股份有限公司研制、生产的吡贝地尔缓释片（50 mg）的药代动力学特征；Les Laboratoires Servier Industrie生产的吡贝地尔缓释片（Trastal®/泰舒达®，50 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of piribedil sustained-release tablets (50 mg) developed and produced by Chongqing Huasen Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Piribedil sustained-release tablets (Trastal®/Tastal®, 50 mg) produced by Les Laboratoires Servier Industrie were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date23 Aug 2024

Sponsor / Collaborator

Chongqing Pharscin Pharmaceutical Co., Ltd.

NCT01007864 / CompletedPhase 3

Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists

The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists.
It should be tested whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance and cognitive performance in patients with Parkinson's disease.

Start Date01 Jan 2010

Sponsor / Collaborator

Desitin Arzneimittel GmbH

[+1]

100 Clinical Results associated with Piribedil

100 Translational Medicine associated with Piribedil

100 Patents (Medical) associated with Piribedil

520

Literatures (Medical) associated with Piribedil

01 May 2024·Chemico-Biological Interactions

A novel arylpiperazine derivative (LQFM181) protects against neurotoxicity induced by 3- nitropropionic acid in in vitro and in vivo models

Article

Author: Georg, Raphaela de Castro ; Pruccoli, Letizia ; Uchenna, Nkaa ; Oliveira, Gerlon de Almeida Ribeiro ; Costa, Elson Alves ; de Carvalho, Flávio Silva ; Tarozzi, Andrea ; Ghedini, Paulo César ; Menegatti, Ricardo ; Rodrigues, Marcella Ferreira ; de Oliveira Ferreira, Pâmela Yasmin ; Lião, Luciano Morais ; Pereira, Robbert Mota ; Batista da Rocha, André Luís ; Sanz, Germán ; Campos, Hericles Mesquita ; Vaz, Boniek Gontijo ; Branco da Silva, Cínthia Rio ; Leite, Jacqueline Alves ; Dos Santos, Fernanda Cristina Alcantara ; Rivello, Bárbara Gonçalves

In the pursuit of novel antioxidant therapies for the prevention and treatment of neurodegenerative diseases, three new arylpiperazine derivatives (LQFM181, LQFM276, and LQFM277) were synthesized through a molecular hybridization approach involving piribedil and butylated hydroxytoluene lead compounds. To evaluate the antioxidant and neuroprotective activities of the arylpiperazine derivatives, we employed an integrated approach using both in vitro (SH-SY5Y cells) and in vivo (neurotoxicity induced by 3-nitropropionic acid in Swiss mice) models. In the in vitro tests, LQFM181 showed the most promising antioxidant activity at the neuronal membrane and cytoplasmic levels, and significant neuroprotective activity against the neurotoxicity induced by 3-nitropropionic acid. Hence, this compound was further subjected to in vivo evaluation, which demonstrated remarkable antioxidant capacity such as reduction of MDA and carbonyl protein levels, increased activities of succinate dehydrogenase, catalase, and superoxide dismutase. Interestingly, using the same in vivo model, LQFM181 also reduced locomotor behavior and memory dysfunction through its ability to decrease cholinesterase activity. Consequently, LQFM181 emerges as a promising candidate for further investigation into its neuroprotective potential, positioning it as a new therapeutic agent for neuroprotection.

01 Apr 2024·CNS Neuroscience & Therapeutics

Comparison of the effectiveness, safety, and costs of anti‐Parkinson drugs: A multiple‐center retrospective study

Article

Author: Zhang, Hua ; Yi, Zhanmiao ; Hui, Jiaojiao ; Li, Wenting ; Zhang, Yuan ; Wang, Ke

AbstractAimsThis study aimed to systematically compare the effectiveness, safety, and costs of different anti‐Parkinson drugs (APDs).MethodsThis is a multi‐center study that retrospectively analyzed the data of 8420 outpatients with PD from 2014 to 2019 across 30 tertiary hospitals in China. The effectiveness was evaluated by changes in total dosages of APDs, normalized by levodopa equivalent dose (LED) and presented as ΔLEDs; levodopa equivalent dose cost (LEDc) represented the daily cost of APDs; and newly added diagnostics were represented as APDs‐related adverse events.ResultsA total of 384 patients with eligible medical records for three consecutive years were enrolled. Patients treated with carbidopa/levodopa or levodopa/benserazide had significantly lower mean ΔLEDs than other groups (p < 0.01), followed by pramipexole and selegiline. The piribedil group had the highest ΔLEDs, with mean differences of 112.56–355.04 mg compared to other groups (p < 0.01). Meanwhile, LEDc in the levodopa/benserazide, carbidopa/levodopa, and piribedil groups were significantly lower than those in pramipexole or selegiline groups ($0.088–0.135/day for levodopa/benserazide; $0.070–0.126/day for carbidopa/levodopa; $0.112–0.138/day for piribedil; $0.290–0.332/day for pramipexole; $0.229–0.544/day for selegiline; p < 0.01). Patients with piribedil had more adverse events, with an incidence rate of 35.7%, followed by levodopa/benserazide (25.6%), selegiline (23.5%), carbidopa/levodopa (23.3%), and pramipexole (16.4%). Pramipexole showed a lower incidence rate of adverse events than piribedil, including neuropsychiatric symptoms (p = 0.006), headache/dizziness (p = 0.016), and gastrointestinal symptoms (p = 0.031).ConclusionsCarbidopa/levodopa or levodopa/benserazide might exhibit better clinical improvement with less medical cost, while piribedil presented less clinical improvement but a higher risk of headache/dizziness, gastrointestinal, and neuropsychiatric symptoms.

05 Feb 2024·Cureus

Delusional Infestation in Parkinson's Disease Secondary to Piribedil Escalation: An Uncommon Case Report

Author: Ait Berri, Maha ; Ahizoune, Aziz

Delusional infestation (DI) is characterized by delusions of being infested by small microorganisms or even inanimate objects without any medical or microbiological evidence. The pathophysiology of DI is not well understood, and there are two types of DI: the primary form, where there is no underlying cause, and the secondary form, which is related to an associated psychiatric disorder, medical condition, or substance use. DI in Parkinson's disease (PD) is rarely reported, and most published cases are due to antiparkinsonian drugs. Piribedil is a dopaminergic agonist used for the symptomatic treatment of PD either as monotherapy or as adjuvant therapy with other antiparkinsonian treatments. We report the case of an 81-year-old man followed for PD at our institution who developed DI after piribedil dose escalation. When DI is secondary to an antiparkinsonian drug, the treatment of choice is based on withdrawing the implicated drug.

100 Deals associated with Piribedil

External Link

KEGG	Wiki	ATC	Drug Bank
D07305	Piribedil	N04BC08	DB12478

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cognitive Dysfunction	CN	Les Laboratoires Servier SAS	-
Vascular Diseases	CN	Les Laboratoires Servier SAS	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis