Delving into the Latest Updates on Choline Fenofibrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Choline fenofibrate (USAN/INN), HEXA

+ [7]

Target

PPARα

Mechanism

PPARα agonists(Peroxisome proliferator-activated receptor α agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

DyslipidemiasHyperlipidemiasHypertriglyceridemia

Inactive Indication

Coronary Artery DiseaseCoronary DiseaseDiabetic macular oedema+ [2]

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie, Inc.

Inactive Organization

Abbott Products LLC

Abbott Laboratories

Drug Highest PhaseApproved

First Approval Date

US (15 Dec 2008),

DyslipidemiasHyperlipidemiasHypertriglyceridemia

Regulation-

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Structure/Sequence

Molecular FormulaC17H15ClO4

InChIKeyMQOBSOSZFYZQOK-UHFFFAOYSA-N

CAS Registry42017-89-0

View All Structures (2)

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.

CTR20234223

/ CompletedNot Applicable

非诺贝特酸胆碱缓释胶囊人体生物等效性试验

[Translation] Bioequivalence study of fenofibrate choline sustained-release capsules in healthy volunteers

主要目的：比较空腹和餐后给药条件下单次口服湖南九典制药股份有限公司提供的非诺贝特酸胆碱缓释胶囊（规格：135 mg）与Abbvie Inc.持证的非诺贝特酸胆碱缓释胶囊（商品名：Trilipix®，规格：135 mg）在健康人群中吸收程度和速度的差异，评价空腹和餐后状态下口服两种制剂的生物等效性。次要目的：评价空腹和餐后给药条件下，单次口服湖南九典制药股份有限公司提供的非诺贝特酸胆碱缓释胶囊（规格：135 mg）与Abbvie Inc.持证的非诺贝特酸胆碱缓释胶囊（商品名：Trilipix®，规格：135 mg）的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of single oral administration of fenofibric acid choline sustained-release capsules (specification: 135 mg) provided by Hunan Jiudian Pharmaceutical Co., Ltd. and fenofibric acid choline sustained-release capsules (trade name: Trilipix®, specification: 135 mg) licensed by Abbvie Inc. in healthy people under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions. Secondary objective: To evaluate the safety of single oral administration of fenofibric acid choline sustained-release capsules (specification: 135 mg) provided by Hunan Jiudian Pharmaceutical Co., Ltd. and fenofibric acid choline sustained-release capsules (trade name: Trilipix®, specification: 135 mg) licensed by Abbvie Inc. under fasting and fed conditions.

Start Date15 Jan 2024

Sponsor / Collaborator

Hunan Jiudian Pharmaceutical Co., Ltd.

CTR20234116

/ CompletedNot Applicable

非诺贝特胶囊在健康成年受试者中的人体生物等效性试验

[Translation] Human bioequivalence study of fenofibrate capsules in healthy adult subjects

主要目的：本研究以江苏万高药业股份有限公司研制的非诺贝特酸胆碱缓释胶囊（规格： 135 mg ）为受试制剂，按生物等效性研究的有关规定，以 Fournier Laboratories Ireland Limited生产的非诺贝特酸胆碱缓释胶囊（规格：135 mg，商品名称：TRILIPIX®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂非诺贝特酸胆碱缓释胶囊和参比制剂非诺贝特酸胆碱缓释胶囊（TRILIPIX®）在健康受试者中的安全性。

[Translation]

Main purpose: This study used fenofibric acid choline sustained-release capsules (specification: 135 mg) developed by Jiangsu Wangao Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, fenofibric acid choline sustained-release capsules (specification: 135 mg, trade name: TRILIPIX®) produced by Fournier Laboratories Ireland Limited were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: To observe the safety of the test preparation fenofibric acid choline sustained-release capsules and the reference preparation fenofibric acid choline sustained-release capsules (TRILIPIX®) in healthy subjects.

Start Date22 Nov 2023

Sponsor / Collaborator

Jiangsu Vanguard Pharmaceutical Co.,Ltd.

100 Clinical Results associated with Choline Fenofibrate

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100 Translational Medicine associated with Choline Fenofibrate

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100 Patents (Medical) associated with Choline Fenofibrate

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69

Literatures (Medical) associated with Choline Fenofibrate

01 Nov 2024·Pest Management Science

A novel approach to managing facility airborne diseases: suppressing air pathogens with smoke aerosols generated from fungicide phase transition

Article

Author: Zhang, Yaozhong ; Han, Chong ; Zhang, Jingzhi ; Zhang, Daxia ; Wang, Ranran ; Liu, Xiaochi ; Liu, Fengqi ; Liu, Feng ; Zou, Nan ; Zhou, Li ; Gao, Haojie ; Mu, Wei

AbstractBACKGROUNDEnvironmental microorganisms are major contributors to the development and spread of disease. Chemical disinfection can inhibit pathogens and play a preventive role against diseases. In agriculture, prolonging the floating time of chemical pesticides in the air has a positive effect on the control of airborne diseases. However, the interaction of chemical pesticides with airborne pathogens is not yet known.RESULTSHere, triazole fungicide was transformed into stable smoke aerosols in order to assess the feasibility of employing phase transition release pesticides for air disinfection. The phase transition had a minimal impact on hexaconazole (Hexa) and myclobutanil (Mycl), with their smoke formation rates remaining consistently >90%. In microscopic morphology, triadimenol (Tria) and epoxiconazole (Epox) are solid, and tebuconazole (Tebu), Hexa, Mycl and difenoconazole (Dife) are liquid. Liquid smoke has advantages over solid smoke in the inhibition of environmental pathogens. The floatability and spatial distribution of fungicide aerosol were optimized by the combination of smoke particles with different properties, so that the fungicide aerosol could meet the conditions of practical application. In practical applications, smoke exhibits a gentler deposition process at the target interface compared to spray, along with a more homogeneous distribution of fungicides. Moreover, fungicide smoke demonstrates superior control efficacy and leaves behind lower residual amounts on fruit.CONCLUSIONIn conclusion, the implementation of fungicide phase transition as a smoke aerosol offers a viable approach to effectively suppress pathogen aerosols and enhance the control of airborne diseases. © 2024 Society of Chemical Industry.

01 Oct 2023·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Evaluation of the antiedematogenic and anti-inflammatory properties of Ximenia americana L. (Olacaceae) bark extract in experimental models of inflammation.

Article

Author: Coutinho, Henrique Douglas Melo ; da Silva, Lucas Yure Santos ; Pessoa, Renata Torres ; de Oliveira, Maria Rayane Correia ; Raposo, António ; da Silva, Bruno Anderson Fernandes ; Medeiros, Cassio Rocha ; Florencio, Sloana Giesta Lemos ; Han, Heesup ; Ribeiro-Filho, Jaime ; Quintans Júnior, Lucindo José ; Yoo, Sunghoon ; Ramos, Andreza Guedes Barbosa ; da Costa, Roger Henrique Sousa ; de Lima Silva, Maria Gabriely ; de Menezes, Irwin Rose Alencar

Edema is one of the obvious indicators of inflammation and a crucial factor to take into account when assessing a substance's capacity to reduce inflammation. We aimed to evaluate the antiedematogenic and anti-inflammatory profile of the hydroethanolic barks extract of Ximenia americana (HEXA). The possible antiedematogenic and anti-inflammatory effect of EHXA (50, 100 mg/kg and 250 mg/kg v.o) was evaluated using the paw edema induced by carrageenan, zymosan, dextran, CFA and by different agents inflammatory (serotonin, histamine, arachidonic acid and PGE₂), and pleurisy model induced by carrageenan and its action on IL-1β and TNF-α levels was also evaluated. HEXA demonstrated a significant antiedematogenic effect at concentrations of 50, 100 and 250 mg/kg on paw edema induced by carrageenan, zymosan and dextran. However, the concentration of 50 mg/kg as standard, demonstrating the effect in the subchronic model, induced CFA with inhibition of 59.06 %. In models of histamine-induced paw edema, HEXA showed inhibition of - 30 min: 40.49 %, 60 min: 44.70 % and 90 min: 48.98 %; serotonin inhibition - 30 min: 57.09 %, 60 min: 66.04 % and 90 min: 61.79 %; arachidonic acid inhibition - 15 min: 36.54 %, 30 min: 51.10 %, 45 min: 50.32 % and 60 min: 76.17 %; and PGE₂ inhibition - 15 min: 67.78 %, 30 min: 62.30 %, 45 min: 54.25 % and 60 min: 47.92 %. HEXA significantly reduced (p < 0.01) leukocyte migration in the pleurisy model and reduced TNF-α and IL-1β levels in pleural lavage (p < 0.0001). The results showed that HEXA has the potential to have an antiedematogenic impact in both acute and chronic inflammation processes, with a putative mode of action including the suppression or regulation of inflammatory mediators.

23 Jun 2023·Vaccine

Did the change of the vaccination schedule effect pneumococcal conjugate vaccination compliance and adherence of premature and mature born infants in Germany? Answers from a claims database analysis.

Article

Author: Schley, Katharina ; Laurenz, Maren ; Jacob, Christian ; Seidel, Karolin ; Borchert, Kathrin ; von Eiff, Christof

BACKGROUNDIn August 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 to a 2+1scheme. For premature infants, the 3+1schedule remained unchanged. Aim was to assess vaccination rates, completeness, and timeliness for PCV stratified by premature and mature infants before and after the recommendation change based on real-world data.METHODSRetrospective claims data analyses were conducted using a comprehensive research database. The study population consisted of all mature and premature infants born in 2013, 2016, or 2018 with an individual follow-up of 24 months using ICD-10-GM codes P07.2 and P07.3 for premature infants. Hexavalent (HEXA) combination vaccination with a consistent 3+1recommendation for premature and mature infants was analyzed as a reference.RESULTSAfter follow-up of 24 months, rates of premature and mature infants receiving ≥1PCV and HEXA vaccination steadily increased since the change of STIKO's recommendation. However, in 2018 (2016/2013), only 47 % (41 %/65 %) of premature but 74 % (72 %/68 %) of mature infants obtained the recommended 3+1 respectively 2+1 PCV doses. At the same age, a consistent increase in complete HEXA vaccination with 3+1 doses was observed over time in premature (2013/2016/2018: 66 %/68 %/70 %) and mature (2013/2016/2018: 69 %/72 %/73 %) infants. Timeliness of PCV and HEXA booster administration remained stable with ∼50 % of all premature and mature infants receiving the booster according to recommended timelines.CONCLUSIONThere is no proven evidence that the reduced PCV schedule for mature infants induced a higher acceptance of vaccination. The rate of unvaccinated infants remained at a considerable level and vaccinations were often delayed. Although the STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, less than half of children showed a completed vaccination series. To protect these vulnerable groups, efforts are needed to increase adherence to the STIKO recommendation especially for premature infants.

100 Deals associated with Choline Fenofibrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D08890	-	C10AB11	DB13873

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyslipidemias	US	AbbVie, Inc.	15 Dec 2008
Hyperlipidemias	US	AbbVie, Inc.	15 Dec 2008
Hypertriglyceridemia	US	AbbVie, Inc.	15 Dec 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Macular Edema	Discovery	NL	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	DE	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	BG	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	IT	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	CZ	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	GB	Abbott Products LLC	01 Sep 2008
Macular Edema	Discovery	DK	Abbott Products LLC	01 Sep 2008
Coronary Artery Disease	Discovery	US	AbbVie, Inc.	01 Feb 2008
Coronary Disease	Discovery	US	Abbott Laboratories	01 Mar 2006
Hyperlipidemia, Familial Combined	Discovery	US	Abbott Laboratories	01 Mar 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01025492 (CTgov)	Phase 4	Hypertriglyceridemia \| Insulin Resistance	24	Placebo+Trilipix	lfgmhrdeeh(ohuyayhgwf) = bjopjuncpv wjmhsfoisg (fbhjjxwvjs, iksuxvfmug - anjpcazyfc) View more	-	01 Sep 2016
NCT00616772 (FIRST, CTgov)	Phase 3	Coronary Artery Disease \| Hyperlipidemia, Familial Combined	682	Atorvastatin+ABT-335 (ABT-335 + Atorvastatin)	pzjbjgkhez(idukfuyeka) = bespbiagcc rxjstjzjut (qptakpggqr, gwtkagygll - jiestnqezq) View more	-	20 Jan 2014
				Placebo+Atorvastatin (Placebo + Atorvastatin)	pzjbjgkhez(idukfuyeka) = yatfopznau rxjstjzjut (qptakpggqr, dnxhmlnhjh - qqthtqtvwx) View more
NCT00463606 (CTgov)	Phase 3	Hypercholesterolemia	760	rosuvastatin calcium+ABT-335 (ABT-335 and Rosuvastatin Calcium)	ghbmymayja(voqxrvolil) = jpoxjdkido uwgdgroydm (xrdxysgsro, tutqueszey - svxxqwcrzx) View more	-	01 Aug 2012
				rosuvastatin calcium (Rosuvastatin Calcium)	ghbmymayja(voqxrvolil) = iuqiwvshoh uwgdgroydm (xrdxysgsro, gpzchfjnee - sugmicfnyd) View more
NCT00673881 (CTgov)	Phase 1/2	Dyslipidemias	25	choline fenofibrate	gdvyqudxjk(cwuismlgbq) = zmacxixndd kvljtycsqb (pstxlghdtt, cxeoirhwgy - jqezfhddqq) View more	-	20 Apr 2011
NCT00491530 (CTgov)	Phase 3	Hyperlipidemia, Familial Combined	310	Rosuvastatin+ABT-335 (ABT-335 + 20 mg Rosuvastatin)	leqkgopqdh(cfwnrevnuy) = kwiteazhqg phlfngemrh (zmahzhvdgr, ukvapryjur - jlgkmbobzv) View more	-	07 Dec 2009
				Simvastatin+ABT-335 (ABT-335 + 40 mg Simvastatin)	leqkgopqdh(cfwnrevnuy) = uzccqwkjon phlfngemrh (zmahzhvdgr, ruoiymgrsu - odlapubwxu) View more
NCT00639158 (CTgov)	Phase 3	Dyslipidemias \| Coronary Disease	543	Atorvastatin+Ezetimibe+ABT-335 (ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe)	ttwgmyyrfc(vrfouprlfc) = yluowoasjh fkpwkvscsv (cbsexqbrud, isilfzview - acwqfqlvim) View more	-	05 Nov 2009
				Placebo+Atorvastatin+Ezetimibe (Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe)	ttwgmyyrfc(vrfouprlfc) = iezkyjgcln fkpwkvscsv (cbsexqbrud, lgvnrqdsqh - hkhlduqtum) View more
NCT00300430 (CTgov)	Phase 3	Coronary Disease \| Hyperlipidemia, Familial Combined	1,911	Rosuvastatin+ABT-335 (ABT-335 + 20 mg Rosuvastatin)	vuxclzejbt(eyytphnxgv) = cyydpceqoh ducadltplm (huasakactw, pemowfrnrl - lbwxskksro) View more	-	23 Jul 2009
				Simvastatin+ABT-335 (ABT-335 + 40 mg Simvastatin)	vuxclzejbt(eyytphnxgv) = tonmqrcnqz ducadltplm (huasakactw, rvjfeiuysp - odincpqpvd) View more
NCT00300456 (CTgov)	Phase 3	Coronary Disease \| Hyperlipidemia, Familial Combined	657	Simvastatin+ABT-335 (ABT-335 + 20 mg Simvastatin)	okxuviyexf(ognhcdxksz) = iuhigtatcn fihyabehgi (jtkpuxfwuu, ghyfrkobvp - lncvezkjqg) View more	-	25 Mar 2009
				Simvastatin+ABT-335 (ABT-335 + 40 mg Simvastatin)	okxuviyexf(ognhcdxksz) = zvslldwlcx fihyabehgi (jtkpuxfwuu, gwosilbeoj - vuspitbxmn) View more
NCT00300469 (CTgov)	Phase 3	Coronary Disease \| Hyperlipidemia, Familial Combined	613	Atorvastatin+ABT-335 (ABT-335 + 20 mg Atorvastatin)	uhlzqkndpp(grjfxlvywv) = qfbbmjecjl vzqqsiupoq (kehzgphiud, ogiakvnsqn - nxuukurpff) View more	-	25 Mar 2009
				Atorvastatin+ABT-335 (ABT-335 + 40 mg Atorvastatin)	uhlzqkndpp(grjfxlvywv) = gukgckavyf vzqqsiupoq (kehzgphiud, itmgijxuqb - ycbmspaptq) View more
NCT00300482 (CTgov)	Phase 3	Coronary Disease \| Hyperlipidemia, Familial Combined	1,445	Rosuvastatin+ABT-335 (ABT-335 + 10 mg Rosuvastatin)	rbehwphabw(bximpgphjp) = hdtdzygvwi nlaoitotjb (osxgljgtgy, glmdjufnzh - ffhucmmily) View more	-	25 Mar 2009
				Rosuvastatin+ABT-335 (ABT-335 + 20 mg Rosuvastatin)	rbehwphabw(bximpgphjp) = uvakwljliu nlaoitotjb (osxgljgtgy, emixokbkdt - beaxvkyidy) View more