[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled bioequivalence study of fluvastatin sodium extended-release tablets in healthy subjects under fasting and fed conditions

主要目的：研究空腹及餐后状态下单次口服受试制剂氟伐他汀钠缓释片（规格：80mg，浙江百代医药科技有限公司持证）与参比制剂氟伐他汀钠缓释片（商品名：Lescol® XL，规格：80mg，Novartis Pharmaceuticals Corp持证）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性。

[Translation]

Main objective: To study the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets (specification: 80 mg, licensed by Zhejiang Baidai Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium sustained-release tablets (trade name: Lescol® XL, specification: 80 mg, licensed by Novartis Pharmaceuticals Corp) in healthy adult subjects after a single oral administration under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting and fed conditions.

Start Date06 Jan 2025

Sponsor / Collaborator

Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.

CTR20243619

/ CompletedNot Applicable

氟伐他汀钠缓释片在健康受试者中随机、开放、单剂量、两制剂、交叉对照空腹及餐后状态下的生物等效性研究

主要目的：研究空腹及餐后状态下单次口服受试制剂氟伐他汀钠缓释片（规格：80mg，浙江恒研医药科技有限公司持证）与参比制剂氟伐他汀钠缓释片（商品名：Lescol® XL，规格：80mg，Novartis Pharmaceuticals Corp持证）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性。

[Translation]

Main objective: To study the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets (specification: 80 mg, licensed by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium sustained-release tablets (trade name: Lescol® XL, specification: 80 mg, licensed by Novartis Pharmaceuticals Corp) in healthy adult subjects after a single oral dose in fasting and fed states, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed states.

Start Date16 Oct 2024

Sponsor / Collaborator

Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.

CTR20242825

/ CompletedNot Applicable

氟伐他汀钠缓释片在健康受试者中空腹状态下的单剂量、随机、开放、四周期、两序列、重复交叉设计的生物等效性试验

[Translation] A single-dose, randomized, open-label, four-period, two-sequence, repeated crossover bioequivalence study of fluvastatin sodium extended-release tablets in healthy subjects under fasting conditions

主要研究目的：研究空腹状态下单次口服受试制剂氟伐他汀钠缓释片（规格：80mg/片，浙江高跖医药科技股份有限公司）与参比制剂氟伐他汀钠缓释片（商品名：来适可®，规格：80mg/片，北京诺华制药有限公司）在健康成年受试者体内的药代动力学，评价两制剂的生物等效性。次要研究目的：评价健康受试者空腹单次口服受试制剂（T）氟伐他汀钠缓释片和参比制剂（R）氟伐他汀钠缓释片（来适可®）后的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets (specification: 80 mg/tablet, Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium sustained-release tablets (trade name: Lescol®, specification: 80 mg/tablet, Beijing Novartis Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary purpose of the study: to evaluate the safety of the test preparation (T) fluvastatin sodium sustained-release tablets and the reference preparation (R) fluvastatin sodium sustained-release tablets (Lescol®) after a single oral administration under fasting conditions in healthy subjects.

Start Date30 Sep 2024

Sponsor / Collaborator

Zhejiang Gaozhi Pharmaceutical Technology Co., LtdStartup

100 Clinical Results associated with Complex dyslipidemia

100 Translational Medicine associated with Complex dyslipidemia

0 Patents (Medical) associated with Complex dyslipidemia

Literatures (Medical) associated with Complex dyslipidemia

01 May 2023·Current atherosclerosis reports

Combined Dyslipidemia in Children and Adolescents: a Proposed New Management Approach.

Review

Author: Kavey, Rae-Ellen W

PURPOSE OF REVIEWCombined dyslipidemia (CD), the predominant abnormal lipid pattern in children and adolescents, is characterized by moderate/severe triglyceride elevation with reduced high-density lipoprotein cholesterol. CD is prevalent, present in 30-50% of obese adolescents. Epidemiologic and lipid sub-population findings demonstrate CD to be highly atherogenic. In the short term, CD responds well to lifestyle change; long-term results are lacking.RECENT FINDINGSMajor longitudinal studies now confirm that CD in childhood predicts early cardiovascular disease events in adults. Targeted nutritional interventions can be safely and effectively introduced in young children. These findings support introduction of a new approach to CD management. New evidence supporting the atherosclerotic risk associated with CD and the effectiveness of lifelong diet interventions is reviewed and a new family-based primordial approach to CD beginning in infancy is proposed. Aligned with existing pediatric care recommendations, this has the potential to significantly decrease the development of CD.

01 May 2018·Canadian Journal of CardiologyQ2 · MEDICINE

The Atherogenic Dyslipidemia Complex and Novel Approaches to Cardiovascular Disease Prevention in Diabetes

Q2 · MEDICINE

Review

Author: Lewis, Gary F ; Stahel, Priska ; Hegele, Robert A ; Xiao, Changting

Despite the effectiveness of low-density lipoprotein (LDL)-lowering strategies for the treatment of diabetic dyslipidemia, significant residual risk of atherosclerotic cardiovascular disease remains. Residual risk might in part be explained by lipid abnormalities that go beyond LDL cholesterol elevation, collectively termed the "atherogenic dyslipidemia complex (ADC)," consisting of hypertriglyceridemia, elevated small dense LDL particles, reduced high-density lipoprotein cholesterol, and high-density lipoprotein particle numbers, increased remnant lipoproteins, and postprandial hyperlipidemia. In this review, we briefly discuss the pathophysiology of the typical dyslipidemia that occurs in insulin-resistant states including obesity, the metabolic syndrome, and type 2 diabetes. Lipid-modifying strategies including lifestyle modification, ezetimibe, statins, fibrates, niacin, and cholesteryl ester transfer protein inhibitors in treating ADC are discussed. With the advent of novel therapies involving antisense oligonucleotides and monoclonal antibodies, new targets can be specifically downregulated to potentially promote lipoprotein clearance or suppress production. We review novel approaches currently undergoing clinical testing and we speculate on their suitability for use in treating ADC for the prevention of atherosclerotic cardiovascular disease. In addition, future targets that might be considered for therapeutic development are discussed.

01 Sep 2015·Journal of Clinical LipidologyQ2 · MEDICINE

Combined dyslipidemia in childhood

Q2 · MEDICINE

Review

Author: Kavey, Rae-Ellen W

Combined dyslipidemia (CD) is now the predominant dyslipidemic pattern in childhood, characterized by moderate-to-severe elevation in triglycerides and non-high-density lipoprotein cholesterol (non-HDL-C), minimal elevation in low-density lipoprotein cholesterol (LDL-C), and reduced HDL-C. Nuclear magnetic resonance spectroscopy shows that the CD pattern is represented at the lipid subpopulation level as an increase in small, dense LDL and in overall LDL particle number plus a reduction in total HDL-C and large HDL particles, a highly atherogenic pattern. In youth, CD occurs almost exclusively with obesity and is highly prevalent, seen in more than 40% of obese adolescents. CD in childhood predicts pathologic evidence of atherosclerosis and vascular dysfunction in adolescence and young adulthood, and early clinical cardiovascular events in adult life. There is a tight connection between CD, visceral adiposity, insulin resistance, nonalcoholic fatty liver disease, and the metabolic syndrome, suggesting an integrated pathophysiological response to excessive weight gain. Weight loss, changes in dietary composition, and increases in physical activity have all been shown to improve CD significantly in children and adolescents in short-term studies. Most importantly, even small amounts of weight loss are associated with significant decreases in triglyceride levels and increases in HDL-C levels with improvement in lipid subpopulations. Diet change focused on limitation of simple carbohydrate intake with specific elimination of all sugar-sweetened beverages is very effective. Evidence-based recommendations for initiating diet and activity change are provided. Rarely, drug therapy is needed, and the evidence for drug treatment of CD in childhood is reviewed.

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