主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服氟哌噻吨美利曲辛片受试制剂（规格：每片含氟哌噻吨0.5mg和美利曲辛10mg，申办者：广东健信制药股份有限公司）和参比制剂（商品名：黛力新®，规格：氟哌噻吨0.5mg和美利曲辛10mg/片，持证商：H.Lundbeck A/S）后的药代动力学特点和生物等效性。次要研究目的研究氟哌噻吨美利曲辛片受试制剂（规格：每片含氟哌噻吨0.5mg和美利曲辛10mg）和参比制剂（商品名：黛力新®，规格：氟哌噻吨0.5mg和美利曲辛10mg/片）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen, applicant: Guangdong Jianxin Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet, licensee: H. Lundbeck A/S) in healthy Chinese adult subjects after a single oral dose under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet) in healthy Chinese adult subjects.

Start Date10 Nov 2024

Sponsor / Collaborator

Guangdong Jianxin Pharmaceutical Co., Ltd.

CTR20233206 / CompletedNot Applicable

氟哌噻吨美利曲辛片在健康受试者中的单剂量、空腹/餐后、随机、开放、两制剂、两周期、两交叉生物等效性研究

[Translation] A single-dose, fasting/fed, randomized, open-label, two-dose, two-period, two-crossover bioequivalence study of flupentixol-melitracen tablets in healthy volunteers

主要研究目的：本研究以成都倍特药业股份有限公司生产的氟哌噻吨美利曲辛片（每片含氟哌噻吨0.5mg和美利曲辛10mg）为受试制剂，原研H.Lundbeck A/S生产的氟哌噻吨美利曲辛片（每片含氟哌噻吨0.5mg和美利曲辛10mg）（商品名：黛力新®（Deanxit®））为参比制剂，评价受试制剂和参比制剂在空腹/餐后条件下给药的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: This study used flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet) produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation and flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet) (trade name: Deanxit®) produced by H. Lundbeck A/S as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting/postprandial conditions. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Nov 2023

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

CTR20221656 / CompletedNot Applicable

氟哌噻吨美利曲辛片在中国健康受试者中单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of flupentixol-melitracen tablets in Chinese healthy subjects

主要研究目的：以植恩生物技术股份有限公司生产的氟哌噻吨美利曲辛片（每片含氟哌噻吨 0.5mg 和美利曲辛 10mg）为受试制剂（T），以H.Lundbeck A/S 生产的氟哌噻吨美利曲辛片（每片含氟哌噻吨 0.5mg 和美利曲辛 10mg，黛力新®）为参比制剂（R），按有关生物等效性试验的规定进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂氟哌噻吨美利曲辛片在健康受试者中的安全性。

[Translation]

Primary study objective: To conduct bioequivalence test in accordance with the relevant provisions of bioequivalence test, using flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet) produced by Zhien Biotechnology Co., Ltd. as the test preparation (T) and flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet, Delexin®) produced by H.Lundbeck A/S as the reference preparation (R). Secondary study objective: To observe the safety of the test preparation and the reference preparation flupentixol-melitracen tablets in healthy subjects.

Start Date24 Jun 2022

Sponsor / Collaborator

Chongqing Zein Pharmaceutical Co. Ltd.

100 Clinical Results associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

100 Translational Medicine associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

100 Patents (Medical) associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

Literatures (Medical) associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

01 Nov 2024·Genes & Diseases

The efficacy and safety of NeuroWell antidepressant dietary supplement, Deanxit, and their combination in the treatment of mild-to-moderate depression: A randomized clinical trial

Article

Author: Wang, Qinglu ; Yin, Hongtao ; Liu, Yajun ; Li, Jinfeng ; Liu, Ping ; Wang, Shanshan ; Liu, Yanqiu ; Wang, Hongwei ; Liu, Yue ; Li, Zhen ; Wang, Wenwen ; Ning, Yaochao ; Liu, Dechen ; Sun, Lei ; Sui, Zhuxin ; Wei, Dianfang ; Wang, Yutong ; Zhang, Hui ; Yin, Honglei ; Deng, Youping ; Wen, Xuejun ; Guo, Shang ; Wang, Yunliang ; Zhou, Qiqi ; Zhang, Kezhong ; Wang, Yanchao ; Zhang, Huaibo ; Geng, Shuang

Then,a total of 242 participants were recruited,and 200 were eventually enrolled and randomly grouped (n Z 50)for the study.None of the patients in any of the four groups had dropped out by 12 wk.

01 Oct 2024·Molecular Neurobiology

Paroxetine Effect on Nerve Growth Factor, Human Neurotrophin-4, Brain-Derived Neurotrophic Factor Levels in Post-stroke Depression

Article

Author: Li, Yan ; Yu, Lamei ; Jin, Yuhua

The aim of this study is to explore paroxetine's effect on nerve growth factor (NGF), human neurotrophin-4 (NT-4), and brain-derived neurotrophic factor (BDNF) levels in post-stroke depression. Ninety-two post-stroke depression patients from April 2021 to April 2023 in our hospital were selected and numbered 1 to 92 after enrollment. Forty-six patients with odd number and 46 patients with even number were, respectively, included in the control and observation group. In addition to basic treatment, control group was treated with flupentixol melitracen tablets orally, and observation group received paroxetine hydrochloride orally. The levels of NGF, NT-4, BDNF, 5-hydroxytryptamine (5-HT), homocysteine (Hcy), noradrenaline (NE), Hamilton Depression Scale (HAMD) changes of National Institute of Health Stroke Scale (NIHSS). NGF, NT-4, and BDNF levels were compared between groups at T0, T1, and T2 levels were higher, and the levels at T2 were higher than those at T1, and observation group levels were higher (P < 0.05); NGF, NT-4, and BDNF levels were compared among groups, time, and interaction. 5-HT, Hcy, and NE levels at T0 were compared between groups; 5-HT and NE levels at T1 and T2 were higher than those at T0, the levels at T2 were higher than those at T1, and observation group levels were higher (P < 0.05); Hcy level at T1 and T2 was lower, its level at T2 was lower than those at T1, and observation group levels were lower (P < 0.05); 5-HT, Hcy, and NE levels were compared among groups, time, and interaction (P < 0.05). HAMD and NIHSS at T0 were compared; T1 and T2 were lower than T0, T2 was lower than T1, and observation group was lower (P < 0.05); HAMD and NIHSS were compared among groups, time, and interaction (P < 0.05). For post-stroke depression, paroxetine treatment can effectively improve NGF, NT-4, BDNF, 5-HT, Hcy, and NE levels and effectively reduce the degree of neurological damage and depression, which has high clinical application value.

01 Mar 2024·Heliyon

Beyond the counter: Navigating the landscape of Deanxit® dispensing – Insights from Jordanian community pharmacies

Article

Author: Ahmad, Rawand E ; Barakat, Muna

BackgroundThis study investigates the dispensing patterns and knowledge of community pharmacists regarding Deanxit®, a combination of melitracen and flupentixol approved for the treatment of depression and anxiety in Jordan.MethodsThis study employed a mixed-methods approach, involving 75 randomly selected pharmacies in two Jordanian governorates (Amman and Irbid). The investigation involved simulated patient scenarios and structured interviews employing a validated tool.ResultsThe analysis revealed that 70.6% of pharmacists were willing to dispense Deanxit® based on simulated scenarios, indicating malpractice. The mean practice score was 0.5867 out of 18, underlining a substantial level of malpractice. Pharmacists demonstrated poor knowledge, with a median score of 2.0 out of 15, reflecting a lack of awareness about Deanxit's labeled indications. Furthermore, 96% reported dispensing without prescriptions, and 62.1% acknowledged encountering cases of improper Deanxit® use.ConclusionThis study provides valuable insights into the current landscape of Deanxit® dispensing patterns, pharmacists' poor knowledge levels, and malpractices in Jordan. By identifying areas for improvement and offering recommendations for intervention, this study contributes to enhancing pharmacy practice and patient care outcomes in the region.

100 Deals associated with Flupenthixol Hydrochloride/Melitracen Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Flupenthixol Hydrochloride/Melitracen Hydrochloride	N06CA02	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Anxiety Disorders	CN	-	-
Depressive Disorder	CN	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Opioid-Related Disorders	Discovery	CN	Reckitt Benckiser Healthcare (UK) Ltd.	14 Oct 2014

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