[Translation] A randomized, open-label, two-dose, two-sequence, four-period, single-dose, completely repeated crossover design bioequivalence study of tandospirone citrate tablets in healthy subjects under fasting and high-fat meal conditions

主要研究目的：以石药集团欧意药业有限公司生产的枸橼酸坦度螺酮片为受试制剂，以Sumitomo Pharma Co., Ltd.持证的枸橼酸坦度螺酮片（商品名：希德®）为参比制剂，按生物等效性试验的相关规定，比较枸橼酸坦度螺酮片在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要研究目的：评价健康受试者单次空腹和高脂餐后口服枸橼酸坦度螺酮片受试制剂和参比制剂后的安全性。

[Translation]

Main research purpose: Tandospirone citrate tablets produced by CSPC Ouyi Pharmaceutical Co., Ltd. were used as the test preparation, and the certified Tandospirone citrate tablets (trade name: Xide®) of Sumitomo Pharma Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of Tandospirone citrate tablets in healthy subjects was compared to evaluate the bioequivalence of the two preparations. Secondary research purpose: Evaluate the safety of the test preparation and reference preparation of Tandospirone citrate tablets after a single oral administration on an empty stomach and after a high-fat meal in healthy subjects.

Start Date28 May 2024

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

CTR20231315 / CompletedNot Applicable

枸橼酸坦度螺酮片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验

[Translation] A human bioequivalence clinical trial of tandospirone citrate tablets in Chinese healthy subjects after single administration under fasting and fed conditions

主要目的：以持证商为Sumitomo Dainippon Pharma Co., Ltd.的枸橼酸坦度螺酮片（商品名：希德（Sediel®），规格：10mg）为参比制剂，以南京海纳医药科技股份有限公司研发的枸橼酸坦度螺酮片（10mg）为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: Using the tandospirone citrate tablets (trade name: Sediel®, specification: 10 mg) of Sumitomo Dainippon Pharma Co., Ltd. as the reference preparation and the tandospirone citrate tablets (10 mg) developed by Nanjing Haina Pharmaceutical Technology Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-sequence, four-period, completely repeated crossover design clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date30 May 2023

Sponsor / Collaborator

Nanjing Haina Pharmaceutical Technology Co Ltd.

CTR20231240 / CompletedNot Applicable

枸橼酸坦度螺酮片在健康受试者中单中心、开放、随机、单剂量、两制剂、两序列、四周期、完全重复空腹状态下的生物等效性试验

[Translation] A single-center, open, randomized, single-dose, two-formulation, two-sequence, four-cycle, completely repeated bioequivalence study of tandospirone citrate tablets in healthy subjects under fasting conditions

主要目的比较空腹给药条件下，山东京卫制药有限公司生产的枸橼酸坦度螺酮片（10mg/片）与Sumitomo Dainippon Pharma Co., Ltd.持证的枸橼酸坦度螺酮片（10mg/片，商品名：希德®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹给药条件下，山东京卫制药有限公司生产的枸橼酸坦度螺酮片（10mg/片）与Sumitomo Dainippon Pharma Co., Ltd.持证的枸橼酸坦度螺酮片（10mg/片，商品名：希德®）的安全性。

[Translation]

Main purpose To compare the differences in the extent and rate of absorption of tandospirone citrate tablets (10 mg/tablet) produced by Shandong Jingwei Pharmaceutical Co., Ltd. and tandospirone citrate tablets (10 mg/tablet, trade name: Xide®) certified by Sumitomo Dainippon Pharma Co., Ltd. in healthy adults under fasting conditions, and to evaluate their bioequivalence. Secondary purpose To evaluate the safety of tandospirone citrate tablets (10 mg/tablet) produced by Shandong Jingwei Pharmaceutical Co., Ltd. and tandospirone citrate tablets (10 mg/tablet, trade name: Xide®) certified by Sumitomo Dainippon Pharma Co., Ltd. under fasting conditions.

Start Date15 May 2023

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

100 Clinical Results associated with Tandospirone Citrate

100 Translational Medicine associated with Tandospirone Citrate

100 Patents (Medical) associated with Tandospirone Citrate

259

Literatures (Medical) associated with Tandospirone Citrate

01 Dec 2024·European Journal of Pharmaceutics and Biopharmaceutics

Deep eutectic solvent combined with permeation enhancer strategy to convert tandospirone from oral to transdermal formulations improving drug bioavailability

Article

Author: Cai, Yu ; Zhang, Yang ; Sun, Peng ; Li, Hui ; Gong, Kaihua ; Liu, Chao ; Fang, Liang

Tandospirone(Tan) is a commonly used drug for anxiety treatment. However, it has a significant first-pass effect and needs to be taken three times a day. To increase the bioavailability of the drug and reduce the number of administrations, this work amid to prepare a Tan patch that can be administered once a day by using the strategy of therapeutic deep eutectic solvent(THEDES) in cooperation with chemical permeation enhancer(CPE). In this study, four organic acids and five permeation enhancers were selected, and the optimized formulation was obtained by single-factor investigation and Box-Behnken design. The optimized formulation could significantly enhance drug loading by 2.5-fold and skin permeation up to 586.6 ± 17 μg/cm² in rats. Based on pharmacokinetic results, compared to oral administration, the drug exhibited a substantially elevated bioavailability, registering a 17-fold increase(from 3.01 % to 52.17 %), alongside a 10-fold rise in the mean residence time(MRT). Meanwhile, the patch was not irritating. The results of the mechanistic study showed that levulinic acid(LeA) acted as a bridge to increase the interaction between the Tan and the matrix and inhibited the crystallization of the drug in the patch, and THEDES together with CPE improved the matrix fluidity and skin permeability. This study provides a reference for the joint application of THEDES and CPEs in patch development.

01 Apr 2024·Neurobiology of Disease

Neonatal hypoxia impairs serotonin release and cognitive functions in adult mice

Article

Author: Lee, Karen Ka Yan ; do Nascimento, Antônia Samia Fernandes ; Amilhon, Bénédicte ; Rosa-Neto, Pedro ; Di Cristo, Graziella ; Moquin, Luc ; Chattopadhyaya, Bidisha

Children who experienced moderate perinatal asphyxia (MPA) are at risk of developing long lasting subtle cognitive and behavioral deficits, including learning disabilities and emotional problems. The prefrontal cortex (PFC) regulates cognitive flexibility and emotional behavior. Neurons that release serotonin (5-HT) project to the PFC, and compounds modulating 5-HT activity influence emotion and cognition. Whether 5-HT dysregulations contribute to MPA-induced cognitive problems is unknown. We established a MPA mouse model, which displays recognition and spatial memory impairments and dysfunctional cognitive flexibility. We found that 5-HT expression levels, quantified by immunohistochemistry, and 5-HT release, quantified by in vivo microdialysis in awake mice, are reduced in PFC of adult MPA mice. MPA mice also show impaired body temperature regulation following injection of the 5-HT_1A receptor agonist 8-OH-DPAT, suggesting the presence of deficits in 5-HT auto-receptor function on raphe neurons. Finally, chronic treatment of adult MPA mice with fluoxetine, an inhibitor of 5-HT reuptake transporter, or the 5-HT_1A receptor agonist tandospirone rescues cognitive flexibility and memory impairments. All together, these data demonstrate that the development of 5-HT system function is vulnerable to moderate perinatal asphyxia. 5-HT hypofunction might in turn contribute to long-term cognitive impairment in adulthood, indicating a potential target for pharmacological therapies.

01 Mar 2024·CNS Neuroscience & Therapeutics

Efficacy and safety of venlafaxine hydrochloride combined with tandospirone citrate for patients with vascular depression accompanied by somatic symptoms: An open‐labeled randomized control trial

Article

Author: Chen, Hui ; Zeng, Guiying ; Zhao, Zijun ; Xiao, Yingchun ; Lin, Ting ; Lin, Yongsen ; Wu, Shufang ; Chen, Xinyan ; Chen, Ronghua ; Lin, Qianwen ; Chen, Hongbin ; Wu, Weiwei ; Liu, Nan

AbstractAimsTo explore the pharmacological treatment of vascular depression (VaDep) and whether the blood levels of neurotransmitters can reflect the VaDep severity.MethodsVaDep patients with somatic symptoms were enrolled and randomly received venlafaxine + tandospirone (Combined Group) or venlafaxine (Monotherapy Group). The treatment efficacy was assessed by Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Patient Health Questionnaire‐15 (PHQ‐15). The levels of blood monoamine neurotransmitters were measured by enzyme‐linked immunosorbent assay.ResultsBoth groups reported a progressive decrease in HAMD, HAMA, and PHQ‐15 scores to below the baseline after the respective treatment. Compared with the Monotherapy Group, the Combined Group reported a significant decrease in HAMD score at week 2 and markedly lower HAMA and PHQ‐15 scores at weeks 1, 2, 4, and 8. Both groups showed a decrease in the levels of blood monoamine neurotransmitters at weeks 4 and 8 when compared with the baseline. A strong positive association was evident between the plasma 5‐HT levels and the HAMD score.ConclusionThe combined therapy rapidly acts on VaDep comorbid with anxiety and somatic symptoms and significantly alleviates the anxiety and somatic symptoms. The plasma levels of 5‐HT may serve as potential objective candidates in evaluating VaDep severity and the efficacy of the undertaken treatment regimen.

100 Deals associated with Tandospirone Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01992	Tandospirone Citrate	N05B	DB12833

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anxiety Disorders	CN	Sumitomo Pharma Co., Ltd.	21 May 2003
Neurotic Disorders	JP	Sumitomo Pharma Co., Ltd.	10 Jul 1996
Psychophysiologic Disorders	JP	Sumitomo Pharma Co., Ltd.	10 Jul 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Age Related Macular Degeneration	Phase 1	-	Alcon Research Ltd.	01 Apr 2009
Geographic Atrophy	Phase 1	-	Alcon Research Ltd.	01 Apr 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00890097 (GATE, CTgov)	Phase 3	Age Related Macular Degeneration \| Geographic Atrophy	772	AL-8309B Ophthalmic Solution (AL-8309B 1.0%)	yndsjfpkfv(erdgjpceju) = igqakklknc fdeqprpwxv (nbcsgotbxu, czyklsjown - jubhkyadoe) View more	-	03 Jul 2014
				AL-8309B Ophthalmic Solution (AL-8309B 1.75%)	yndsjfpkfv(erdgjpceju) = uxmoktqdiq fdeqprpwxv (nbcsgotbxu, saeueowfnq - crcqjrbjnc) View more

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