[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.

CTR20241569 / CompletedNot Applicable

甲磺酸倍他司汀片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of betahistine mesylate tablets in healthy subjects after single oral administration on an empty stomach or after a meal

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单次口服受试制剂（甲磺酸倍他司汀片，天津恒翊药业有限公司）与参比制剂（甲磺酸倍他司汀片，商品名：敏使朗®，卫材（中国）药业有限公司）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单次口服甲磺酸倍他司汀片（6mg）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of the test preparation (Betahistine Mesylate Tablets, Tianjin Hengyi Pharmaceutical Co., Ltd.) and the reference preparation (Betahistine Mesylate Tablets, trade name: Minshilan®, Eisai (China) Pharmaceutical Co., Ltd.) in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation of Betahistine Mesylate Tablets (6 mg) taken orally in healthy Chinese subjects.

Start Date27 May 2024

Sponsor / Collaborator

Tian Jin Heng Yi Yao Ye You Xian Gong Si

CTR20231015 / CompletedNot Applicable

在健康成年受试者中进行的单中心、随机、开放、两周期、两序列、交叉、单次给药试验设计，评价空腹/餐后状态下的生物等效性研究。

[Translation] A single-center, randomized, open-label, two-period, two-sequence, crossover, single-dose study was conducted in healthy adult subjects to evaluate the bioequivalence under fasting/fed conditions.

主要目的：本研究以厦门恩成制药有限公司研发的甲磺酸倍他司汀片（规格：6 mg）为受试制剂，按生物等效性研究的有关规定，以原研地产化药品厂家卫材（中国）药业有限公司生产的甲磺酸倍他司汀片（商品名：敏使朗®，规格：6 mg）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察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（商品名：敏使朗®）在健康受试者中的安全性。

[Translation]

Primary objective: This study used betahistine mesylate tablets (specification: 6 mg) developed by Xiamen Encheng Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, betahistine mesylate tablets (trade name: Minshilang®, specification: 6 mg) produced by Eisai (China) Pharmaceutical Co., Ltd., an original localized drug manufacturer, were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation betahistine mesylate tablets and the reference preparation betahistine mesylate tablets (trade name: Minshilang®) in healthy subjects.

Start Date11 Apr 2023

Sponsor / Collaborator

Xiamen Encheng 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

01 Oct 2024·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY B-BIOLOGY

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

Article

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

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

Background:

Cervicogenic 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.

Methods:

A 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.

Discussion:

This 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 registration:

Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.

Protocol version:

1.0, November 20, 2022.

01 Nov 2023·Brain stimulation

Meniere Disease treated with transcutaneous auricular vagus nerve stimulation combined with betahistine Mesylate: A randomized controlled trial

Article

Author: Wu, Yunqing ; Cao, Kai ; Wu, Dong ; Wang, Yu ; Sun, Jingyi ; Liu, Bo ; Liu, Gang ; Rong, Peijing ; Duan, Jinping ; Yang, Jun ; Zhang, Yi

BACKGROUND:

Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment.

OBJECTIVE:

To determine whether taVNS as an adjunctive therapy could relieve symptoms and improve the quality of life in patients with Meniere disease.

METHODS:

In this Single-center, single blind, randomized trial, participants were assigned to transcutaneous auricular vagus nerve stimulation (taVNS) group and sham taVNS group. The primary outcome measures comprised Tinnitus Handicap Inventory, Dizziness Handicap Inventory, Pure Tone Auditory, Visual analogue scale of aural fullness. Secondary outcome measures comprised the 36-Item Short Form Health Survey, video head impulse test, and the caloric test.

RESULTS:

After 12 weeks, the THI (-11.00, 95%CI, -14.87 to -7.13; P < 0.001), DHI (-47.26, 95%CI, -50.23 to -44.29; P < 0.001), VAS of aural fullness (-2.22, 95%CI, -2.95 to -1.49; P<0.01), and Pure Tone Thresholds (-7.07, 95%CI, -9.07 to -5.06; P<0.001) were significantly differed between the two groups. In addition, SF36(14.72, 95%CI, 11.06 to 18.39; P < 0.001), vHIT (RD, 0.26, 95 % CI, -0.44 to -0.08, RR, 0.43, 95 % CI, 0.22 to 0.83, P < 0.01), and the caloric test (RD, -0.24, 95 % CI, -0.43 to -0.04, RR, 0.66, 95 % CI, 0.44 to 0.95, P = 0.02) have significant difference between two group, respectively.

CONCLUSIONS:

These findings suggest that taVNS combined with Betahistine Mesylate relieve symptoms and improve the quality of life for patients with Meniere Disease. taVNS can be considered an adjunctive therapy in treatment of Meniere Disease.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT05328895.

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

06 Nov 2022

·www.thepharmaletter.com

Eisai divests rights to Myonal and Merislon for Asian markets to DKSH

Japanese drug major Eisai (TYO: 4523) today announced that it has entered into an agreement to divest its rights for muscle relaxant Myonal (eperisone hydrochloride) and vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) in Asia to a subsidiary of Switzerland-based DKSH Holding Ltd. DKSH recently partnered with life cycle management company Pharmanovia, to bring high-quality pharmaceutical products to patients across the Asia Pacific. Eisai noted that, in its Asia and Latin America Pharmaceuticals Business (ALA Region), it is shifting to a product portfolio centered on new global products in its strategic areas of neurology and oncology. Eisai believes that this divestiture will accelerate the pursuit of the best marketing mix in the ALA Region. Under the terms of the agreement, Eisai will receive an undisclosed contractual up-front payment, and also plans to supply the products. Eisai will retain its manufacturing rights to and continue to distribute the products in countries such as Japan, China and South Korea.

AcquisitionLicense out/inDrug Approval

100 Deals associated with Betahistine Mesilate

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KEGG	Wiki	ATC	Drug Bank
D01592	-	N07CA01	-

R&D Status

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

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