Delving into the Latest Updates on Fenofibric acid with Synapse

Primary objective: To conduct human bioavailability and bioequivalence studies of fenofibric acid tablets (test preparation) produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the drug of the original research company in the United States (reference preparation). Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date14 Oct 2019

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20191478 / CompletedNot Applicable

非诺贝酸片随机、开放、两周期、两交叉单次空腹状态下健康人体生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of fenofibric acid tablets in healthy volunteers under fasting conditions

主要目的：长春海悦药业股份有限公司生产的非诺贝酸片（受试制剂）与美国原研公司药品（参比制剂）进行人体生物利用度与生物等效性试验。次要目的：观察受试制剂与参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To conduct human bioavailability and bioequivalence studies of fenofibric acid tablets (test preparation) produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the drug of the original research company in the United States (reference preparation). Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date18 Jul 2019

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20190653 / CompletedPhase 1

一项开放、随机、在中国健康男性和女性受试者中进行的单次和多次服用ABT-335后非诺贝特酸的药代动力学研究

[Translation] An open-label, randomized, pharmacokinetic study of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects

主要目的：确定健康中国男性和女性受试者单次和多次服用ABT-335后非诺贝特酸的药代动力学特征。安全性目的：评价健康中国男性和女性受试者单次和多次服用ABT-335 45 mg和135 mg胶囊制剂后的安全性和耐受性。

[Translation]

Primary objective: To determine the pharmacokinetic profile of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects. Safety objective: To evaluate the safety and tolerability of ABT-335 45 mg and 135 mg capsule formulations after single and multiple doses in healthy Chinese male and female subjects.

Start Date08 May 2019

Sponsor / Collaborator

Fournier Laboratories Ireland Ltd.

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100 Clinical Results associated with Fenofibric acid

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100 Translational Medicine associated with Fenofibric acid

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100 Patents (Medical) associated with Fenofibric acid

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340

Literatures (Medical) associated with Fenofibric acid

01 Dec 2024·Applied Microbiology and Biotechnology

Enzymatic and non-enzymatic removal of organic micropollutants with spent mushroom substrate of Agaricus bisporus

Article

Author: Kemperman, Antoine J B ; Wösten, Han A B ; Kleijburg, Fleur E L ; van der Meer, Walter G J ; van Brenk, Brigit

AbstractWater bodies are increasingly contaminated with a diversity of organic micropollutants (OMPs). This impacts the quality of ecosystems due to their recalcitrant nature. In this study, we assessed the removal of OMPs by spent mushroom substrate (SMS) of the white button mushroom (Agaricus bisporus) and by its aqueous tea extract. Removal of acesulfame K, antipyrine, bentazon, caffeine, carbamazepine, chloridazon, clofibric acid, and N, N-diethyl-meta-toluamide (DEET) by SMS and its tea was between 10 and 90% and 0–26%, respectively, in a 7-day period. Sorption to SMS particles was between 0 and 29%, which can thus not explain the removal difference between SMS and its tea, the latter lacking these particles. Carbamazepine was removed most efficiently by both SMS and its tea. Removal of OMPs (except caffeine) by SMS tea was not affected by heat treatment. By contrast, heat-treatment of SMS reduced OMP removal to < 10% except for carbamazepine with a removal of 90%. These results indicate that OMP removal by SMS and its tea is mediated by both enzymatic and non-enzymatic activities. The presence of copper, manganese, and iron (0.03, 0.88, and 0.33 µg L-1, respectively) as well as H2O2 (1.5 µM) in SMS tea indicated that the Fenton reaction represents (part of) the non-enzymatic activity. Indeed, the in vitro reconstituted Fenton reaction removed OMPs > 50% better than the teas. From these data it is concluded that spent mushroom substrate of the white button mushroom, which is widely available as a waste-stream, can be used to purify water from OMPs.

01 Jan 2024·Results in Chemistry

A facile synthesis of 2-(4-((4-chlorophenyl)(hydroxy)methyl) phenoxy)-2-methylpropanoic acid: Metabolite of anti-hyperlipidemic drug Fenofibrate

Article

Author: Haq, Wahajul ; Majethia, Greesha N. ; Balendiran, Ganesaratnam K.

Synthesis and characterization of drug metabolites has emerged as an important area of research in consideration to the significant contribution of studies on metabolites in drug research. The present work comprises synthesis of 2-(4-((4-chlorophenyl)(hydroxy)methyl) phenoxy)-2-methylpropanoic acid, a metabolite of anti-hyperlipidemic drug fenofibrate. The desired compound was prepared by two different synthetic routes. The ketone group of fenofibric acid was reduced using sodium borohydride in one route whereas the hydrolysis of isopropyl ester of the reduced fenofibrate was achieved by the mild alkaline hydrolysis in the other path. Both the ways of synthesis furnished the desired compound in excellent yield and purity. The new synthetic congener was characterized by spectroscopic methods.

01 Nov 2023·Drug metabolism and disposition: the biological fate of chemicals

Human Carboxylesterase 1A Plays a Predominant Role in Hydrolysis of the Anti-Dyslipidemia Agent Fenofibrate in Humans.

Article

Author: Sun, Meng-Ru ; Zhang, Ya ; Ge, Guang-Bo ; Hou, Xu-Dong ; Zhang, Feng ; Li, Hong-Xin ; Song, Yun-Qing ; Song, Li-Lin

Fenofibrate, a marketed peroxisome proliferator-activated receptor-α (PPARα) agonist, has been widely used for treating severe hypertriglyceridemia and mixed dyslipidemia. As a canonical prodrug, fenofibrate can be rapidly hydrolyzed to release the active metabolite (fenofibric acid) in vivo, but the crucial enzyme(s) responsible for fenofibrate hydrolysis and the related hydrolytic kinetics have not been well-investigated. This study aimed to assign the key organs and crucial enzymes involved in fenofibrate hydrolysis in humans, as well as reveal the impact of fenofibrate hydrolysis on its non-PPAR-mediated biologic activities. Our results demonstrated that fenofibrate could be rapidly hydrolyzed in the preparations from both human liver and lung to release fenofibric acid. Reaction phenotyping assays coupling with chemical inhibition assays showed that human carboxylesterase 1A (hCES1A) played a predominant role in fenofibrate hydrolysis in human liver and lung, while human carboxylesterase 2A (hCES2A) and human monoacylglycerol esterase (hMAGL) contributed to a very lesser extent. Kinetic analyses showed that fenofibrate could be rapidly hydrolyzed by hCES1A in human liver preparations, while the inherent clearance of hCES1A-catalyzed fenofibrate hydrolysis is much higher (>200-fold) than than that of hCES2A or hMAGL. Biologic assays demonstrated that both fenofibrate and fenofibric acid showed very closed Nrf2 agonist effects, but fenofibrate hydrolysis strongly weakens its inhibitory effects against both hCES2A and hNtoum. Collectively, our findings reveal that the liver is the major organ and hCES1A is the predominant enzyme-catalyzing fenofibrate hydrolysis in humans, while fenofibrate hydrolysis significantly reduces inhibitory effects of fenofibrate against serine hydrolases. SIGNIFICANCE STATEMENT: Fenofibrate can be completely converted to fenofibric acid in humans and subsequently exert its pharmacological effects, but the hydrolytic pathways of fenofibrate in humans have not been well-investigated. This study reported that the liver was the predominant organ and human carboxylesterase 1A was the crucial enzyme involved in fenofibrate hydrolysis in humans.

100 Deals associated with Fenofibric acid

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Fenofibric acid	-	DB13873

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyslipidemias	CN	Changchun Haiyue Pharmaceutical Co., Ltd	10 May 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemias	Phase 1	-	Hanmi Pharmaceutical Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01472380 (CTgov)	Phase 1	-	30	Efavirenz (Efavirenz Alone)	etxetzdpar(nbvnqrnxwd) = smikcsacnf alwibkuksm (kmbgbeesfy, adbxprgtvu - metvlxwetx) View more	-	23 Jul 2012
				Fenofibric Acid+Efavirenz (Efavirenz With Fenofibric Acid)	etxetzdpar(nbvnqrnxwd) = dokkvzspty alwibkuksm (kmbgbeesfy, ngvcdfkwve - txrmykpzge) View more
ARVO2011	Not Applicable	Diabetic Retinopathy	-	Fenofibric Acid (FA)	xfqgpynbst(qvgdyeosvx) = knfxpvztvm wahentlypl (uzvjkgypbe )	Positive	01 Apr 2011
				Fenofibric Acid	xfqgpynbst(qvgdyeosvx) = faejocngtl wahentlypl (uzvjkgypbe )
NCT00960687 (CTgov)	Phase 1	-	54	Fenofibric Acid (Fenofibric Acid 105 mg Tablets)	(qqltbnleqb) = puurnrazze zkisinbsme (nirhomxace, fojjkzaiwv - wxqkiohgqk) View more	-	14 Oct 2009
				Fenofibrate (Fenofibrate 145 mg Tablets)	(qqltbnleqb) = zfuuodhlay zkisinbsme (nirhomxace, lnxfyvaciq - bbooccrxch) View more
NCT00960570 (CTgov)	Phase 1	-	30	Efavirenz 600 mg	leueunerkq(mgmflpdxfe) = jxijimeqwq hnikeyhweb (fjhgbqrosp, fdcfflvasd - qqsklbppwe) View more	-	14 Oct 2009
NCT00961116 (CTgov)	Phase 1	-	54	Fenofibric Acid (Fenofibric Acid 105 mg Tablets)	gwxobupuoz(zohvppvvav) = avyowqpjwo kgeeyybkqt (bhshqdkqah, uulbidfsjt - bmgbvmgczt) View more	-	01 Oct 2009
				Fenofibrate (Fenofibrate 145 mg Tablets)	gwxobupuoz(zohvppvvav) = qzsgjtjdxb kgeeyybkqt (bhshqdkqah, ikhlqhscza - bquhpujfen) View more