主要目的：采用单中心、随机、开放、四周期完全重复交叉、单剂量给药设计，比较浙江华海药业股份有限公司生产的氟伐他汀钠缓释片（规格：80 mg）与北京诺华制药有限公司持证的氟伐他汀钠缓释片（规格：80 mg）在中国健康人群中吸收程度和吸收速度的差异，评价生物等效性。次要目的：评价氟伐他汀钠缓释片（规格：80 mg）受试制剂和参比制剂在健康受试者体内的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and absorption rate between fluvastatin sodium sustained-release tablets (specification: 80 mg) produced by Zhejiang Huahai Pharmaceutical Co., Ltd. and fluvastatin sodium sustained-release tablets (specification: 80 mg) certified by Beijing Novartis Pharmaceutical Co., Ltd. in healthy Chinese population using a single-center, randomized, open, four-period completely repeated crossover, single-dose administration design, and to evaluate bioequivalence. Secondary objective: To evaluate the safety of the test and reference preparations of fluvastatin sodium sustained-release tablets (specification: 80 mg) in healthy subjects.

Start Date02 Sep 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20242471 / CompletedNot Applicable

非诺贝特酸胆碱缓释胶囊（135mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of fenofibrate choline extended-release capsules (135 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择AbbVie Inc.为持证商的非诺贝特酸胆碱缓释胶囊（商品名：Trilipix，规格：135mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂非诺贝特酸胆碱缓释胶囊（规格：135mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂非诺贝特酸胆碱缓释胶囊（规格：135mg）和参比制剂非诺贝特酸胆碱缓释胶囊（商品名：Trilipix，规格：135mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, fenofibrate choline sustained-release capsules (trade name: Trilipix, specification: 135mg) with AbbVie Inc. as the licensee were selected as the reference preparation, and the test preparation fenofibrate choline sustained-release capsules (specification: 135mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to human bioequivalence test under fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation fenofibrate choline sustained-release capsules (specification: 135mg) and the reference preparation fenofibrate choline sustained-release capsules (trade name: Trilipix, specification: 135mg) in healthy subjects.

Start Date13 Aug 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242824 / Active, not recruitingNot Applicable

氟伐他汀钠缓释片在健康受试者中餐后状态下的单剂量、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 volunteers in the fed state

主要研究目的：研究餐后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：评价健康受试者餐后单次口服受试制剂（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 in the fed state, 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 in healthy subjects.

Start Date06 Aug 2024

Sponsor / Collaborator

Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd

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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