[Translation] A randomized, open-label, two-period, double-crossover pharmacokinetic comparison of vildagliptin extended-release tablets and vildagliptin tablets in Chinese healthy subjects under fasting conditions

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂维格列汀缓释片（生产厂家：泰州越洋医药开发有限公司）与对比制剂维格列汀片（持证商：Novartis Europharm Ltd.）后在中国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。次要目的：观察受试制剂维格列汀缓释片和对比制剂维格列汀片在中国健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, compare the pharmacokinetic behavior of the test preparation vildagliptin extended-release tablets (manufacturer: Taizhou Yueyang Pharmaceutical Development Co., Ltd.) and the comparative preparation vildagliptin tablets (licensed by: Novartis Europharm Ltd.) in healthy Chinese subjects after oral administration under fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation vildagliptin extended-release tablets and the comparative preparation vildagliptin tablets in healthy Chinese subjects.

Start Date23 Oct 2024

Sponsor / Collaborator

Overseas Pharmaceuticals Ltd.

CTR20243744 / RecruitingPhase 1

枸橼酸托法替布多释片在中国健康受试者中的随机、开放、三周期、三交叉餐后状态下药代动力学试验

[Translation] A randomized, open-label, three-period, three-crossover pharmacokinetic study of tofacitinib citrate extended-release tablets in Chinese healthy subjects under fed conditions

主要目的：以越洋医药开发（广州）有限公司研制的枸橼酸托法替布多释片（规格：10mg）为受试制剂，枸橼酸托法替布片（规格：5mg，持证商：先声药业有限公司）为对照制剂1，枸橼酸托法替布缓释片（规格：11mg，持证商：石药集团欧意药业有限公司）为对照制剂2。比较餐后状态下口服受试制剂、对照制剂1、对照制剂2在中国健康受试者体内的枸橼酸托法替布血药浓度及主要药代动力学参数（AUC、Cmax、tmax、t1/2等），评价受试制剂、对照制剂1、对照制剂2的枸橼酸托法替布的AUC等效情况以及PK特征比对。次要目的：评价中国健康受试者餐后状态下口服受试制剂枸橼酸托法替布多释片和对比制剂1枸橼酸托法替布片、对比制剂2枸橼酸托法替布缓释片后的安全性和耐受性。

[Translation]

Main purpose: Tofacitinib citrate extended-release tablets (specification: 10 mg) developed by Yueyang Pharmaceutical Development (Guangzhou) Co., Ltd. were used as the test preparation, tofacitinib citrate tablets (specification: 5 mg, license holder: Xiansheng Pharmaceutical Co., Ltd.) were used as control preparation 1, and tofacitinib citrate sustained-release tablets (specification: 11 mg, license holder: CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd.) were used as control preparation 2. To compare the blood concentrations and main pharmacokinetic parameters (AUC, Cmax, tmax, t1/2, etc.) of tofacitinib citrate in healthy Chinese subjects after oral administration of the test preparation, control preparation 1, and control preparation 2 in the postprandial state, and to evaluate the AUC equivalence of tofacitinib citrate and the PK characteristics of the test preparation, control preparation 1, and control preparation 2. Secondary objective: To evaluate the safety and tolerability of the test formulation, tofacitinib citrate extended-release tablets, the comparison formulation 1, tofacitinib citrate tablets, and the comparison formulation 2, tofacitinib citrate sustained-release tablets, in Chinese healthy subjects after oral administration in the fed state.

Start Date15 Oct 2024

Sponsor / Collaborator

Overseas Pharmaceuticals Ltd.

CTR20243572 / RecruitingPhase 1

在中国健康受试者中随机、开放、两周期、双交叉空腹状态下阿哌沙班多释片与阿哌沙班片药代动力学比较试验

[Translation] A randomized, open-label, two-period, double-crossover pharmacokinetic comparison of apixaban extended-release tablets and apixaban tablets under fasting conditions in healthy Chinese subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂阿哌沙班多释片（生产厂家：泰州越洋医药开发有限公司）与对比制剂阿哌沙班片（持证商：齐鲁制药（海南）有限公司）后在中国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。次要目的：观察受试制剂阿哌沙班多释片和对比制剂阿哌沙班片在中国健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation, apixaban multi-release tablets (manufacturer: Taizhou Yueyang Pharmaceutical Development Co., Ltd.) and the comparative preparation, apixaban tablets (certificate holder: Qilu Pharmaceutical (Hainan) Co., Ltd.) in healthy Chinese subjects after oral administration under fasting state, using pharmacokinetic parameters as the primary endpoint evaluation index, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation, apixaban multi-release tablets, and the comparative preparation, apixaban tablets in healthy Chinese subjects.

Start Date26 Sep 2024

Sponsor / Collaborator

Taizhou Overseas Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Overseas Pharmaceuticals Ltd.

0 Patents (Medical) associated with Overseas Pharmaceuticals Ltd.

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01 Jan 2017·Colloids and Surfaces B: Biointerfaces

Novel self-assembled tacrolimus nanoparticles cross-linking thermosensitive hydrogels for local rheumatoid arthritis therapy

Article

Author: Xiong, Subin ; Wang, Hanning ; Huang, Wencong ; Wen, Xiaoguang ; Chen, Fang ; Chen, Jiali ; Wang, Kaiyuan ; Tao, Jin ; Wu, Huimin ; Chen, Yuqi

The aim was to explore the potential application of novel self-assembled nanoparticles cross-linking thermosensitive hydrogels composed of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol (Soluplus) and tacrolimus (FK-506) for local therapy of rheumatoid arthritis (RA). The sol-gel transition temperature (T_sol-gel), gelation time, rheological behaviors, in vitro release, in vivo gelation and retention, and therapeutic efficacy against adjuvant-induced arthritis (AIA) rats were compared between the Soluplus hydrogels and widely studied poloxamer 407 (P407) delivery systems. In sol, the spherical and uniform FK506 loaded Soluplus nanoparticles (Soluplus-SNPs) were self-assembled with encapsulation efficiency of 99.5±1.5% and particle size of 73.9±2.9nm. The decreased T_sol-gel of Soluplus-SNPs hydrogels was associated with the addition of salts, elevation of pH and ionic strength. The optimal T_sol-gel of Soluplus-SNPs with concentrations of 10%-30% in phosphate buffer (50mM, pH 7.4) was from 37.4±0.1°C to 32.8±0.3°C and the gelation time was not greater than 2min. Soluplus-SNPs gelling systems showed lower viscosity and wider range concentrations in sol state at 25°C and stronger gel strength at 37°C than P407, which resulting in longer sustained release of FK506 but without burst-release in vitro, and longer retention time in the local injection site in vivo. The therapeutic efficacy to treat AIA rats was significantly enhanced from d10 to d17 after a single dose of FK506 loaded in 10% and 20% Soluplus-SNPs hydrogels. In conclusion, Soluplus-SNPs hydrogel is a potential sustainable delivery system for FK506 to treat RA locally.

International Journal of Molecular Sciences

Axenic Culture of Caenorhabditis elegans Alters Lysosomal/Proteasomal Balance and Increases Neuropeptide Expression

Article

Author: Vierstraete, Andy ; Dhondt, Ineke ; Wu, Ping ; Braeckman, Bart P. ; Vandemeulebroucke, Lieselot ; Rasulova, Madina ; Cai, Huaihan

Axenically cultured C. elegans show many characteristic traits of worms subjected to dietary restriction, such as slowed development, reduced fertility, and increased stress resistance. Hence, the term axenic dietary restriction (ADR) is often applied. ADR dramatically extends the worm lifespan compared to other DR regimens such as bacterial dilution. However, the underlying molecular mechanisms still remain unclear. The primary goal of this study is to comprehensively investigate transcriptional alterations that occur when worms are subjected to ADR and to estimate the molecular and physiological changes that may underlie ADR-induced longevity. One of the most enriched clusters of up-regulated genes under ADR conditions is linked to lysosomal activity, while proteasomal genes are significantly down-regulated. The up-regulation of genes specifically involved in amino acid metabolism is likely a response to the high peptide levels found in axenic culture medium. Genes related to the integrity and function of muscles and the extracellular matrix are also up-regulated. Consistent down-regulation of genes involved in DNA replication and repair may reflect the reduced fertility phenotype of ADR worms. Neuropeptide genes are found to be largely up-regulated, suggesting a possible involvement of neuroendocrinal signaling in ADR-induced longevity. In conclusion, axenically cultured worms seem to rely on increased amino acid catabolism, relocate protein breakdown from the cytosol to the lysosomes, and do not invest in DNA maintenance but rather retain muscle integrity and the extracellular matrix. All these changes may be coordinated by peptidergic signaling.

100 Deals associated with Overseas Pharmaceuticals Ltd.

100 Translational Medicine associated with Overseas Pharmaceuticals Ltd.

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