Delving into the Latest Updates on Hydrochlorothiazide/Valsartan with Synapse

主要目的：评价在健康受试者中空腹和餐后单次口服受试制剂（缬沙坦氢氯噻嗪片，深圳奥萨制药有限公司，规格：每片含缬沙坦80 mg，氢氯噻嗪12.5 mg）与参比制剂（复代文®，Novartis Pharma Schweiz AG，规格：每片含缬沙坦80 mg，氢氯噻嗪12.5 mg）的生物等效性。次要目的：观察空腹和餐后口服受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of a single oral dose of the test formulation (valsartan hydrochlorothiazide tablets, Shenzhen Osa Pharmaceutical Co., Ltd., specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) and a reference formulation (CoDiovan®, Novartis Pharma Schweiz AG, specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) in healthy subjects on an empty stomach and after a meal. Secondary objective: To observe the safety of the test formulation and the reference formulation when taken orally on an empty stomach and after a meal.

Start Date29 May 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

CTR20240954 / CompletedNot Applicable

健康受试者在空腹和餐后状态下单次口服缬沙坦氢氯噻嗪片的随机、开放、两序列、两制剂、四周期、完全重复交叉的生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of valsartan and hydrochlorothiazide tablets in healthy subjects in the fasting and fed state

主要研究目的：试验空腹和餐后状态下单次口服受试制剂缬沙坦氢氯噻嗪片（规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），浙江金立源药业有限公司）与参比制剂缬沙坦氢氯噻嗪片（Co-Diovan®，规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），Novartis Farma S.p.A.(I)生产）在健康成年受试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：评价健康受试者在空腹和餐后状态下，单次口服缬沙坦氢氯噻嗪片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to test the pharmacokinetics of the test preparation valsartan hydrochlorothiazide tablets (specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), Zhejiang Jinliyuan Pharmaceutical Co., Ltd.) and the reference preparation valsartan hydrochlorothiazide tablets (Co-Diovan®, specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), produced by Novartis Farma S.p.A. (I)) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation of valsartan hydrochlorothiazide tablets in healthy subjects after a single oral administration in the fasting and fed state.

Start Date29 May 2024

Sponsor / Collaborator

Zhejiang Kinglyuan Pharmaceutical Co. Ltd.

CTR20222172 / CompletedNot Applicable

健康受试者在空腹和餐后状态下单次口服缬沙坦氢氯噻嗪片的随机、开放、两序列、两制剂、四周期、完全重复交叉的生物等效性试验。

[Translation] A randomized, open-label, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of valsartan and hydrochlorothiazide tablets in healthy subjects 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缬沙坦氢氯噻嗪片（规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），浙江英格莱制药有限公司生产）与参比制剂缬沙坦氢氯噻嗪片（Co-Diovan®，规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），Novartis Farma S.p.A.(I).Italy生产）在健康成年受试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：评价健康受试者在空腹和餐后状态下，单次口服缬沙坦氢氯噻嗪片受试制剂和参比制剂后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation valsartan hydrochlorothiazide tablets (specification: 80/12.5mg (each tablet contains 80mg valsartan, 12.5mg hydrochlorothiazide), produced by Zhejiang Yinggelai Pharmaceutical Co., Ltd.) and the reference preparation valsartan hydrochlorothiazide tablets (Co-Diovan®, specification: 80/12.5mg (each tablet contains 80mg valsartan, 12.5mg hydrochlorothiazide), produced by Novartis Farma S.p.A. (I).Italy) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test preparation and reference preparation of valsartan hydrochlorothiazide tablets in healthy subjects after a single oral administration in the fasting and fed state.

Start Date19 Sep 2022

Sponsor / Collaborator

Zhejiang Yinggelai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Valsartan

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100 Translational Medicine associated with Hydrochlorothiazide/Valsartan

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100 Patents (Medical) associated with Hydrochlorothiazide/Valsartan

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18

Literatures (Medical) associated with Hydrochlorothiazide/Valsartan

01 Jun 2023·Nutrition

Intermittent food restriction upregulates critical hypothalamic genes involved in energy regulation imbalance

Article

Author: Batista, Leandro Oliveira ; Albuquerque, Kelse Tibau de ; Concha Vilca, Carlos ; Tavares do Carmo, Maria das Graças ; Rosas Fernández, Mariana

The effect of intermittent food restriction (IFR) on the Central Nervous System is unclear, especially when alternated with an obesity-inducing diet (DIO). This study aimed to evaluate key genes involved in energy-regulation imbalance in the hypothalamus after IFR and DIO alternation. Therefore, 45-d-old female Wistar rats were divided into 4 groups: standard control (ST-C), fed with an ad libitum standard diet; DIO control (DIO-C), fed with a DIO in the first and last 15 d of the intervention and a standard diet between the 16th and 45th day; standard restricted (ST-R), fed with a standard diet in the first and last 15 d of the intervention followed by IFR at 50% of the ST-C diet between the 16th and 45th day; and DIO restricted (DIO-R), fed with a DIO in the first and last 15 d of the intervention and subjected to IFR under the same conditions as the ST-R group. At 105 d of age, animals were euthanized, and the hypothalamus was removed for quantitative polymerase chain reaction analysis. The ST-R and DIO-R groups showed higher inhibitor of nuclear factor kappa-B kinase subunit beta (P < 0.001; P = 0.029) and nuclear factor kappa B (P < 0.001; P = 0.029) gene expression when compared with the ST-C group. The same held true for the JNK (P = 0.001; P = 0.003) and PPARα genes (both P < 0.001). Instead, the DIO-R group exhibited higher CCL5 gene expression than the ST-C (P = 0.001) and DIO-C (P < 0.001) groups, whereas all groups had higher SOCS3 gene expression than did the ST-C group. These data together suggest that IFR, whether combined with DIO or not, alters the expression of critical genes involved in energy regulation imbalance in the hypothalamus, which warrants caution and more research, because long-term usage might be hazardous.

01 Apr 2023·International Journal of Social RoboticsQ3 · COMPUTER SCIENCE

Socially Aware Robot Obstacle Avoidance Considering Human Intention and Preferences

Q3 · COMPUTER SCIENCE

Article

Author: Hu, Boyi ; Chen, Yuhao ; Smith, Trevor ; Gu, Yu ; Hewitt, Nathan

In order to navigate safely and effectively with humans in close proximity, robots must be capable of predicting the future motions of humans. This study first consolidates human studies in motion, intention, and preference into a discretized human model that can readily be used in robotics decision making algorithms. Cooperative Markov Decision Process (Co-MDP), a novel framework that improves upon Multiagent MDPs, is then proposed for enabling socially aware robot obstacle avoidance. Utilizing the consolidated and discretized human model, Co-MDP allows the system to (1) approximate rational human behavior and intention, (2) generate socially-aware robotic obstacle avoidance behavior, and (3) remain robust to the uncertainty of human intention and motion variance. Simulations of a human-robot co-populated environment verify Co-MDP as a feasible obstacle avoidance algorithm. In addition, the anthropomorphic behavior of Co-MDP was assessed and confirmed with a human-in-the-loop experiment. Results reveal that participants can not directly differentiate agents that were controlled by human operators from Co-MDP, and the reported confidences of their choices indicates that the predictions from participants were backed by behavioral evidence rather than random guesses. Thus the main contributions for this paper are: consolidating past human studies of rational human behavior and intention into a simple, discretized model; the development of Co-MDP: a robotic decision framework that can utilize this human model and maximize the joint utility between the human and robot; and an experimental design for evaluation of the human acceptance of obstacle avoidance algorithms.

01 Apr 2022·SmallQ2 · MATERIALS SCIENCE

The Multicomponent Synergistic Effect of Sandwich Structure Hierarchical Nanofibers for Enhanced Sodium Storage

Q2 · MATERIALS SCIENCE

Article

Author: Zhang, Baoliang ; Chen, Junjie ; Zhang, Fangrong ; Wang, Ting ; Tian, Nan ; Zhang, Qiuyu

AbstractConstructing hierarchical micro/nanostructures as anodes for sodium ion batteries is an important approach for exploiting efficient energy storage devices. Herein, sandwich structure hierarchical nanofibers composed of hollow carbon fibers as the substrate, and MoS2 as the interlayer with Co and/or ZnS nanoparticles anchoring in carbon skeletons as the outer shell (carbon nanofiber/MoS2/Co‐ZnS⊂NC) are prepared via a multistep reaction strategy. Profiting from the unique hierarchical structure, abundant migration channels of Na+, and multicomponent synergistic effects, the rapid diffusion kinetics are ensured and the utilization of active materials is maximized. The coaxial structure can evenly disperse volumetric strain, making structural stability guaranteed. Hierarchical nanofibers deliver a high reversible capacity of 352.3 mAh g−1 at 5.0 A g−1 over 3000 cycles. A discharge capacity of 182.5 mAh g−1 is retained even after 10 000 cycles at 10.0 A g−1 as well as a high rate capacity of 202.0 mAh g−1 up to 30 A g−1. The optimal atomic ratio of Co element is further verified by the kinetic analysis. The full‐cells assembled with Na3V2(PO4)3 cathode provide a high capacity of 179.2 mAh g−1 at 1.0 A g−1 for 500 cycles. Combining in situ and ex situ characterizations and theoretical calculations, possible sodium storage mechanisms and the origin of superior electrochemical properties are revealed.

100 Deals associated with Hydrochlorothiazide/Valsartan

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hypertension	US	Novartis Pharmaceuticals Corp.	06 Mar 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 1	US	Novartis AG	01 Oct 2005

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2014	Phase 4	Diabetes Mellitus, Type 2 \| Hypertension	130	Ramipril/hydrochlorothiazide	(methvmptlg) = pacywsqtsd wuyqfmgpuz (tkwdzdbsso )	Positive	17 Sep 2014
				Valsartan/hydrochlorothiazide	(methvmptlg) = covhpnsshz wuyqfmgpuz (tkwdzdbsso )
NCT00698646 (Pubmed)	Phase 4	Hypertension	384	Valsartan/Hydrochlorothiazide combination therapy	(qznztqqelz) = vziekfnfns hvooxyzdcc (hiwptidyqc )	-	01 Apr 2012
				Hydrochlorothiazide monotherapy	(qznztqqelz) = qfmjubkjch hvooxyzdcc (hiwptidyqc )
NCT00698646 (Pubmed \| J Clin Hypertens (Greenwich))	Phase 4	Hypertension	384	valsartan/hydrochlorothiazide 160/12.5 mg	lwhyprqhzp(cqoscltgum) = wximsypqxq jeplzpxgiw (gwwgtdncbu ) View more	-	01 Oct 2011
				hydrochlorothiazide 12.5 mg	lwhyprqhzp(cqoscltgum) = qwoiicjemm jeplzpxgiw (gwwgtdncbu ) View more
NCT00698646 (ValVET, Pubmed \| Blood Press Monit)	Phase 4	Hypertension	108	Valsartan/hydrochlorothiazide 160/12.5 mg combination therapy	rxtkmnwxxm(krluyyavke) = nkcrwhzxxd gehguauvoq (locrbyfzxt )	Positive	01 Aug 2011
				Hydrochlorothiazide 12.5 mg monotherapy	rxtkmnwxxm(krluyyavke) = axgqqimjhj gehguauvoq (locrbyfzxt )
NCT00698646 (ValVET, CTgov)	Phase 4	Essential Hypertension	384	Valsartan (Valsartan)	mznyfndmfv(kplmuxucoy) = jerjbvgshq ziktlqbfxa (ofsxujzupw, zvfqynkqdj - usiaapggon) View more	-	15 Dec 2010
				HCTZ (HCTZ)	mznyfndmfv(kplmuxucoy) = eoivnpkdtz ziktlqbfxa (ofsxujzupw, fylmyeetbl - bclowtchhf) View more