[Translation] A randomized, open-label, four-period, two-sequence, repeated crossover design bioequivalence study protocol of pinaverium bromide tablets in healthy adult study participants after single oral administration in the fasting state and after a high-fat meal

主要研究目的：研究重庆圣华曦药业股份有限公司生产的匹维溴铵片（50mg）在中国健康研究参与者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征，并以ABBOTT LABORATORIES LIMITED持有，MYLAN LABORATORIES SAS生产的匹维溴铵片（商品名：得舒特®/Dicetel®；规格：50mg）为参比制剂，进行生物等效性评价。次要研究目的：初步考察匹维溴铵片受试制剂和参比制剂在健康研究参与者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetic characteristics of Pinaverium Bromide Tablets (50 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese health study participants in the fasting state and after a high-fat meal, and to evaluate the bioequivalence of Pinaverium Bromide Tablets (trade name: Dicetel®/Dicetel®; specification: 50 mg) produced by MYLAN LABORATORIES SAS and owned by ABBOTT LABORATORIES LIMITED as the reference preparation. Secondary study objective: To preliminarily investigate the safety of the test preparation and reference preparation of Pinaverium Bromide Tablets in healthy study participants.

Start Date11 Apr 2025

Sponsor / Collaborator

Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

CTR20244456

/ RecruitingNot Applicable

评估受试制剂匹维溴铵片（规格：50 mg）与参比制剂Dicetel®（规格：50 mg）在健康成年参与者空腹和餐后状态下的单中心、随机、开放、单剂量、四周期、两序列、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test formulation, Pinaverium Bromide Tablets (strength: 50 mg), and the reference formulation, Dicetel® (strength: 50 mg), in healthy adult participants in the fasting and fed state.

主要研究目的：研究空腹和餐后状态下单次口服受试制剂匹维溴铵片（规格：50 mg，浙江京新药业股份有限公司生产）与参比制剂匹维溴铵片（Dicetel®，规格：50 mg，持证商：Abbott Laboratories Limited）在健康成年参与者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂匹维溴铵片（规格：50 mg）和参比制剂匹维溴铵片（Dicetel®，规格：50 mg）在健康成年参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Pinaverium Bromide Tablets (Specification: 50 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation Pinaverium Bromide Tablets (Dicetel®, Specification: 50 mg, Licensee: Abbott Laboratories Limited) in healthy adult participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary purpose of the study: to evaluate the safety of the test preparation Pinaverium Bromide Tablets (Specification: 50 mg) and the reference preparation Pinaverium Bromide Tablets (Dicetel®, Specification: 50 mg) in healthy adult participants.

Start Date16 Mar 2025

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

NCT06936800

/ Enrolling by invitationNot ApplicableIIT

Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP): a Single-center, Double-blind, Randomized, Placebo-controlled Trial.

This study aims to evaluate whether perioperative pinaverium bromide (a calcium antagonist) reduces post-ESWL complications (pancreatitis, abdominal pain, infection) in chronic pancreatitis patients with pancreatic duct stones ≥5mm. A single-center, randomized, double-blind, placebo-controlled design will be used, with 288 participants allocated to either pinaverium bromide (100mg tid) or placebo before and after p-ESWL.

Start Date01 Mar 2025

Sponsor / Collaborator

Shandong University

100 Clinical Results associated with Pinaverium bromide

100 Translational Medicine associated with Pinaverium bromide

100 Patents (Medical) associated with Pinaverium bromide

261

Literatures (Medical) associated with Pinaverium bromide

02 Jan 2025·Growth Factors

Exploring the mechanisms of Shugan-Jieyu-Jianpi formula against irritable bowel syndrome combined with non-alcoholic fatty liver disease by network pharmacology and experimental validation

Article

Author: Ouyang, Jun ; Xie, Dongyu ; Wei, Ling ; Xi, Biao ; Shi, Yaxiang ; Yu, Xiaowen ; Chen, Xuan ; Wu, Defeng

The study was aimed to investigate the clinical effect and mechanism of Shugan-Jieyu-Jianpi (SGJYJP) formula for the treatment of irritable bowel syndrome (IBS) combined with non-alcoholic fatty liver disease (NAFLD). The clinical efficacy of SGJYJP was evaluated in 54 patients with IBS-NAFLD. The potential molecular mechanism of SGJYJP formula was investigated by network pharmacology. Animal models were constructed to explore the related mechanism. From clinical studies, the total effective rate of patients in SGJYJP group was significantly higher than that in pinaverium group. The protein expression of TGFB1 was declined in IBS-NAFLD rats, together with the increased expression of PTGS2 and TNF, which was abolished by SGJYJP treatment. SGJYJP significantly reduced the expression of TNF signalling related molecules of TRAF2, caspase-8, and elevated the expression of Bcl-xl in IBS-NAFLD animal models. SGJYJP may exert therapeutic effect on IBS-NAFLD by targeting PTGS2, TGFB1, and TNF genes and TNF signalling.

01 Nov 2024·Cell Reports

A platform of functional studies of ESCC-associated gene mutations identifies the roles of TGFBR2 in ESCC progression and metastasis

Article

Author: Li, Yaxin ; Zou, Yang ; Wan, Xudong ; Wang, Manli ; Xiong, Xingyu ; Hu, Bing ; Guo, Linjie ; Lin, Huahang ; Chen, Longqi ; Liu, Hongyu ; Zhang, Shiyu ; Chen, Xuelan ; Chen, Chong ; Lu, Zhenghao ; Na, Feifei ; Wang, Jian ; Zhou, Jianfeng ; Lu, Runda ; Dai, Siqi ; Liu, Yixin ; Du, Jiajia ; Li, Yuan ; Wang, Yingjie ; Zhang, Qi ; Pan, Xiangyu ; Zhang, Mengsha ; Liu, Yu ; Luo, Xiangmeng ; Wang, Lu ; Tan, Ping ; Wu, Baohong ; Zhong, Ailing ; Han, Zongkai

Genomics studies have detected numerous genetic alterations in esophageal squamous cell carcinoma (ESCC). However, the functions of these mutations largely remain elusive, partially due to a lack of feasible animal models. Here, we report a convenient platform with CRISPR-Cas9-mediated introduction of genetic alterations and orthotopic transplantation to generate a series of primary ESCC models in mice. With this platform, we validate multiple frequently mutated genes, including EP300, FAT1/2/4, KMT2D, NOTCH2, and TGFBR2, as tumor-suppressor genes in ESCC. Among them, TGFBR2 loss dramatically promotes tumorigenesis and multi-organ metastasis. Paradoxically, TGFBR2 deficiency leads to Smad3 activation, and disruption of Smad3 partially restrains the progression of Tgfbr2-mutated tumors. Drug screening with tumor organoids identifies that pinaverium bromide represses Smad3 activity and restrains Tgfbr2-deficient ESCC. Our studies provide a highly efficient platform to investigate the in vivo functions of ESCC-associated mutations and develop potential treatments for this miserable malignancy.

28 Oct 2024·Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences

Synergistic antibacterial effects of pinaverium bromide and oxacillin against Staphylococcus epidermidis.

Article

Author: Yuan, Lehong ; She, Pengfei

OBJECTIVESStaphylococcus epidermidis (S. epidermidis) adheres to the surface of medical devices, forming highly drug-resistant biofilms, which has made the development of novel antibacterial agents against S. epidermidis and its biofilms a key research focus. By drug repurposing, this study aims to explore the combinational antimicrobial effects between pinaverium bromide (PVB), a L-type calcium channel blocker, and oxacillin (OXA) against S. epidermidis.METHODSClinical isolates of S. epidermidis were collected from January to September 2022 at the Department of Clinical Laboratory of the Third Xiangya Hospital, Central South University. The minimal inhibitory concentrations (MICs) of PVB and OXA were determined using the broth microdilution method. Checkerboard assays and time-kill curves were performed to assess the fractional inhibitory concentration index and synergistic bactericidal efficiency of the drug combination. Resistance selection assays evaluated PVB's ability to inhibit the development of OXA resistance. Biofilm eradication assays, combined with confocal laser scanning microscopy (CLSM) and the persister cell quantification, were conducted to evaluate the effect of PVB and OXA on drug-resistant biofilms and persister cells. The mechanisms of PVB action were further investigated using transmission electronic microscopy (TEM), reactive oxygen species (ROS) quantification, and ATP quantification.RESULTSThe MICs of PVB and OXA against the standard strain S. epidermidis RP62A were both 8 μg/mL. Checkerboard assays showed that the fractional inhibitory concentration index (FICI) for the combination was 0.250 0 for RP62A and ranged from 0.187 5 to 0.500 0 for clinical isolates, indicating synergistic effects. Resistance selection assays demonstrated that PVB not only failed to induce resistance but also effectively inhibited the development of OXA resistance. The combination of 1×MIC of PVB and OXA reduced biofilm biomass (A_{570 nm}) from (2.36±0.46) to (1.12±0.39) (t=3.504, P=0.02). CLSM revealed significant biofilm structural disruption and an increased proportion of dead bacteria. Additionally, after 4 hours of treatment, the total persister cell count was reduced from lg(7.73±0.21) to lg(2.79±0.43) (t=4.143, P=0.014). Synergistic biofilm eradication was further confirmed in clinical isolates. TEM revealed that PVB caused significant bacterial structural damage. The combination of OXA and PVB significantly induced ROS production, increasing the relative fluorescence intensity from (30 000.00±2 000.00) to (45 666.67±2 081.67) (t=10.68, P<0.001), and markedly reduced ATP generation, lowering the relative fluorescence intensity form (565.00±33.18) to (205.67±35.23) (t=4.932, P=0.003).CONCLUSIONSThe combination of PVB and OXA exhibits significant synergistic antimicrobial activity against S. epidermidis, its biofilms, and persister cells. This combination holds promise as a potential alternative therapy for biofilm-associated infections caused by S. epidermidis.

100 Deals associated with Pinaverium bromide

External Link

KEGG	Wiki	ATC	Drug Bank
D07094	Pinaverium bromide	A03AX04	DBSALT001130

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Gastrospasm	China	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis	Preclinical	China	Southern Medical University	01 Jan 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2014	Not Applicable	Irritable Bowel Syndrome	-	Pinaverium bromide 100 mg + simethicone 300 mg	mrcodrjgfh(zykoufcxmo) = mdqwvhihxm enhvaxgvcu (krdynmzivj )	-	01 Oct 2014

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