[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of betahistine mesylate tablets (6 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择卫材（中国）药业有限公司为持证商的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）为参比制剂，对兰西哈三联制药有限公司生产，北京哈三联科技有限责任公司提供的受试制剂甲磺酸倍他司汀片（规格：6mg）进行空腹和餐后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，评估两种制剂在空腹和餐后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甲磺酸倍他司汀片和参比制剂甲磺酸倍他司汀片的安全性。

[Translation]

Main purpose of the study: According to the relevant provisions of bioequivalence tests, Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) of which Eisai (China) Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation Betahistine Mesylate Tablets (specification: 6mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. and provided by Beijing Ha Sanlian Technology Co., Ltd. were subjected to human bioequivalence tests for fasting and postprandial administration, 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 and postprandial administration conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation Betahistine Mesylate Tablets and the reference preparation Betahistine Mesylate Tablets in healthy subjects.

Start Date29 Aug 2024

Sponsor / Collaborator

Harbin Medisan Pharmaceutical Co., Ltd.

CTR20241882

/ CompletedNot Applicable

甲磺酸倍他司汀片（6mg）在中国健康志愿者中空腹/餐后状态下的人体生物等效性试验

[Translation] Human bioequivalence study of betahistine mesylate tablets (6 mg) in Chinese healthy volunteers under fasting/fed conditions

主要目的：按有关生物等效性试验的规定，选择卫材（中国）药业有限公司为持证商的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）为参比制剂，对北京紫萌医药科技有限公司提供的受试制剂甲磺酸倍他司汀片（规格：6mg）进行空腹和餐后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和餐后给药条件下的生物等效性。次要目的：观察健康志愿受试者口服受试制剂甲磺酸倍他司汀片（规格：6mg）和参比制剂甲磺酸倍他司汀片（商品名：敏使朗®，规格：6mg）的安全性。

[Translation]

Main purpose: According to the relevant provisions of bioequivalence test, Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) of which Eisai (China) Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation Betahistine Mesylate Tablets (specification: 6mg) provided by Beijing Zimeng Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test of fasting and postprandial administration, 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 and postprandial administration conditions. Secondary purpose: To observe the safety of oral administration of the test preparation Betahistine Mesylate Tablets (specification: 6mg) and the reference preparation Betahistine Mesylate Tablets (trade name: Minshilang®, specification: 6mg) by healthy volunteers.

Start Date18 Jun 2024

Sponsor / Collaborator

Beijing Wista Pharma Co., Ltd.

CTR20241929

/ CompletedNot Applicable

甲磺酸倍他司汀片在健康受试者空腹和餐后状态下的随机、开放、单剂量、两制剂、两周期、两序列、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover bioequivalence study of betahistine mesylate tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后单次给药条件下，由浙江仙琚制药股份有限公司生产的甲磺酸倍他司汀片（规格：6mg，受试制剂）与卫材（中国）药业有限公司持证的甲磺酸倍他司汀片（规格：6mg，参比制剂）在健康受试者中吸收程度和速度的差异。次要目的：通过观察健康受试者单次口服受试制剂或参比制剂后的安全性指标，评价甲磺酸倍他司汀片的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate of Betahistine Mesylate Tablets (Specification: 6 mg, test preparation) produced by Zhejiang Xianju Pharmaceutical Co., Ltd. and Betahistine Mesylate Tablets (Specification: 6 mg, reference preparation) certified by Eisai (China) Pharmaceutical Co., Ltd. in healthy subjects under single-dose conditions of fasting and postprandial administration. Secondary objective: To evaluate the safety of Betahistine Mesylate Tablets by observing the safety indicators of healthy subjects after a single oral administration of the test preparation or the reference preparation.

Start Date04 Jun 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

100 Clinical Results associated with Betahistine Mesilate

100 Translational Medicine associated with Betahistine Mesilate

100 Patents (Medical) associated with Betahistine Mesilate

Literatures (Medical) associated with Betahistine Mesilate

12 Jan 2025·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Clinical efficacy of Fu's subcutaneous needling based on "multi-joint muscle spiral balance chain" theory for cervical vertigo and its effect on blood flow velocity of vertebral artery].

Article

Author: Liu, Zhixiang ; Gong, Meng ; Guo, Hong ; Jia, Peng ; Li, Pei ; Xiao, Renyan ; Jin, Song

OBJECTIVETo observe the clinical efficacy of Fu's subcutaneous needling based on "multi-joint muscle spiral balance chain" theory for cervical vertigo (CV) and its effect on blood flow velocity of vertebral artery.METHODSA total of 60 patients with CV were randomized into a Fu's subcutaneous needling group and a medication group, 30 cases in each one. In the Fu's subcutaneous needling group, Fu's subcutaneous needling was delivered at Dazhui (GV14), the flexible tube was retained for 5 min after sweeping manipulation, and the treatment was given once every other day, 3 times a week for 3 weeks. In the medication group, betahistine mesylate tablet and diclofenac sodium dual-release enteric capsule were taken orally for continuous 3 weeks. Before treatment, after treatment, and in follow-up of one month after treatment completion, the scores of dizziness handicap inventory (DHI) and visual analogue scale (VAS) were observed; before and after treatment, the blood flow velocity of vertebral artery was measured by transcranial Doppler, and the clinical efficacy was evaluated after treatment in the two groups.RESULTSAfter treatment and in follow-up, each item scores and total scores of DHI were decreased compared with those before treatment in the two groups (P<0.05); the VAS scores after treatment in the two groups, as well as the VAS score in follow-up of the Fu's subcutaneous needling group, were decreased compared with those before treatment (P<0.05). In the Fu's subcutaneous needling group, after treatment and in follow-up, the physical scores and the total scores of DHI, and the VAS scores were lower than those in the medication group (P<0.05); in follow-up, the emotional and functional scores of DHI were lower than those in the medication group (P<0.05). After treatment, the mean blood flow velocity (Vm) of the left vertebral artery (LVA) and the right vertebral artery (RVA) was increased compared with that before treatment in the two groups (P<0.05), and the Vm of LVA and RVA in the Fu's subcutaneous needling group was higher than that in the medication group (P<0.05). The total effective rate was 100.0% (30/30) in the Fu's subcutaneous needling group, which was superior to 73.3% (22/30) in the medication group (P<0.05).CONCLUSIONFu's subcutaneous needling based on the "multi-joint muscle spiral balance chain" theory can effectively alleviate the vertigo and neck pain, and improve the blood flow velocity of vertebral artery in CV patients, and has a long-term therapeutic effect.

01 Oct 2024·Journal of Photochemistry and Photobiology B: Biology

Betahistine mesylate reduces the damage of blue light exposure in Drosophila model

Article

Author: Shen, Jie ; Zhao, Zhiwei ; Li, Xiangyu ; He, Jianan

Previous studies have demonstrated the efficacy of betahistine mesylate in treating vertigo and angioneurotic headache, enhancing microcirculation, and facilitating histamine release. However, limited research has been conducted on the drug's potential in mitigating blue light-induced damage. Thus, this study utilized Drosophila as the model organism and employed the Siler model to investigate the impact of various concentrations of betahistine mesylate on the lifespan, under 3000 lx blue light irradiation. At the same time we measure food intake, spontaneous activity, and sleep duration of Drosophila. The findings of this study indicate that a high concentration of betahistine mesylate can decrease the initial mortality (b0) in male flies, mitigating the damage of blue light to Drosophila. Consequently, this delays the aging process in male Drosophila and extends their average lifespan. After betahistine mesylate ingestion, locomotor activity upon blue light exposure decreased significantly in male Drosophila. In conclusion, this study offers initial evidence supporting the investigation of the regulatory mechanisms of betahistine mesylate on lifespan and its potential anti-blue light effects.

01 Oct 2024·Contemporary Clinical Trials Communications

Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial

Article

Author: Ning, Jiawei ; Zhang, Yujie ; Yuan, Weian ; Chai, Yongli ; Kong, Lingjun ; Zhao, Ye ; Zhan, Yunfan ; Liu, Kaoqiang

BackgroundCervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.MethodsA multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.DiscussionThis trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.Trial registrationClinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.Protocol version1.0, November 20, 2022.

News (Medical) associated with Betahistine Mesilate

02 Apr 2024

·www.pharmaceutical-technology.com

Eisai to divest rights for two therapies to Kaken

Eisai will continue to focus on creating and delivering products to target disease. Credit: mkfilm/Shutterstock.com. Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical . The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. See Also: China accepts Innovent-HUTCHMED’s endometrial cancer therapy NDA Magazine: What’s next for AAV gene therapies in 2024? The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and global health. Kaken is a research and development-driven pharmaceutical company that focuses on orthopaedics and dermatology. Earlier this month, Eisai received approval for the amyloid beta-directed antibody Leqembi (lecanemab-irmb) in China to treat mild cognitive impairment associated with Alzheimer’s disease (AD) and mild AD dementia. Leqembi, developed in partnership with BioArctic, will be available in the region in the third quarter of 2024. The approval in China is based on the international Phase III Clarity AD study. Eisai will be responsible for distribution and information provision through expert medical representatives.

Drug ApprovalPhase 3AcquisitionLicense out/inBiosimilar

29 Mar 2024

·firstwordpharma.com

Eisai to transfer rights for vertigo, muscle spasm drugs in Japan

Eisai said Friday that it agreed to sell Japanese rights for the vertigo treatment Merislon (betahistine mesilate) and the antispasmodic drug Myonal (eperisone hydrochloride) to Kaken Pharmaceutical.The drugs have long been used by patients in Japan since their respective launches there decades ago, according to the Eisai. "Divesting rights for these products to Kaken, which has strengths in the products' disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients," it added.Eisai will receive JPY 3.8 billion ($25 million) under the deal, and will proceed with the transfer of marketing capabilities by March 2025, followed by the transfer of manufacturing and marketing approval.Towards the end of 2022, the drugmaker agreed to offload US rights to its epilepsy drug Fycompa (perampanel) to Catalyst Pharmaceuticals for an upfront payment of $160 million.The company said it doesn't anticipate any changes to its consolidated financial forecast for the period ending March 31, 2024, as a result of the latest deal.

License out/inAcquisition

29 Mar 2024

·www.eisai.com

EISAI TO DIVEST RIGHTS FOR MERISLON® AND MYONAL® IN JAPAN TO KAKEN PHARMACEUTICAL

For Print（143KB） March 29, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to divest its rights for vertigo and equilibrium disturbance treatment Merislon® (generic name: betahistine mesilate) and muscle relaxant Myonal® (generic name: eperisone hydrochloride) in Japan to Kaken Pharmaceutical Co., Ltd. (Headquarters: Tokyo, “Kaken”). Merislon and Myonal have been widely used by patients in Japan for a long time since their launch in 1969 and 1983, respectively. Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients. Under the terms of the agreement, Eisai will receive 3.8 billion yen for the transfer, and proceed with transfer of the marketing capability by March 2025, followed by the transfer of the manufacturing and marketing approval. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2024. Driven by our hhc concept, Eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: Neurology, Oncology and Global Health. As an hhceco company, Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries. Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors] Kaken Pharmaceutical Co., Ltd. (“Kaken”) is a pharmaceutical company, established in 1948, and its corporate philosophy is to help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. Kaken is an R&D-driven pharmaceutical company focusing on dermatology and orthopedics, and are committed to creating and providing innovative medicines to bring smiles to the faces of patients, their families, and the medical professionals involved in their treatment. For more information, please visit https://www.kaken.co.jp/english/ Full text（143KB）

License out/inDrug ApprovalAcquisition

100 Deals associated with Betahistine Mesilate

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Indication	Country/Location	Organization	Date
Vertigo	JP	Eisai Co., Ltd.	01 Jan 1969
Meniere Disease	CN	-	-

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