Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega-3-Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single-Blind, Randomized, Placebo-Controlled Trial.

scientific article published on 9 June 2017

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega-3-Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single-Blind, Randomized, Placebo-Controlled Trial. is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1002/CPDD.360
P698PubMed publication ID28597973

P2093author name stringToshitaka Yajima
Hitoshi Shimada
Hyosung Kim
Catarina Nilsson
Torbjörn Lundström
Yoshinori Noda
P2860cites workOverview of prescription omega-3 fatty acid products for hypertriglyceridemiaQ28251391
Serum triglycerides and risk of coronary heart disease among Japanese men and womenQ32066276
Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan -2012 versionQ34344173
Omega-3 carboxylic acids (Epanova): a review of its use in patients with severe hypertriglyceridemiaQ34439420
Triglycerides and remnant particles as risk factors for coronary artery diseaseQ34498572
Comparison of various lipid variables as predictors of coronary heart disease in Japanese men and women with type 2 diabetes: subanalysis of the Japan Diabetes Complications StudyQ35898244
Steady-state bioavailability of prescription omega-3 on a low-fat diet is significantly improved with a free fatty acid formulation compared with an ethyl ester formulation: the ECLIPSE II studyQ37225366
Epanova(®) and hypertriglyceridemia: pharmacological mechanisms and clinical efficacyQ38086841
Development and validation of a sensitive and selective UHPLC-MS/MS method for simultaneous determination of both free and total eicosapentaeonic acid and docosahexenoic acid in human plasmaQ42845775
Highly purified eicosapentaenoic acid reduces cardio-ankle vascular index in association with decreased serum amyloid A-LDL in metabolic syndromeQ43274967
Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery diseaseQ43698602
Triglyceride and glucose intolerance as a risk factor for coronary heart diseaseQ43762941
Eicosapentaenoic acid improves endothelial function in hypertriglyceridemic subjects despite increased lipid oxidizabilityQ44227550
Effects of eicosapentaenoic acid on platelet activation markers and cell adhesion molecules in hyperlipidemic patients with Type 2 diabetes mellitusQ44434979
Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trialQ46919603
Fasting triglyceride is a significant risk factor for coronary artery disease in middle-aged Japanese men.Q46963223
Mortality risk of triglyceride levels in patients with coronary artery disease.Q50908726
Impact of hypertriglyceridemia on endothelial dysfunction during statin ± ezetimibe therapy in patients with coronary heart disease.Q51373690
Effects of Docosahexaenoic Acid on the Endothelial Function in Patients with Coronary Artery DiseaseQ57711672
Increased triglyceride may determine the sites of coronary arterial lesionsQ68616112
Plasma lipid abnormalities and risk factors for coronary artery disease in Japanese subjects with diabetes mellitus and glucose intoleranceQ72554117
The long-term effect of eicosapentaenoic acid on serum levels of lipoprotein (a) and lipids in patients with vascular diseaseQ73514453
A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova(®) compared to Lovaza(®) in a pharmacokinetic single-dose evaluation) studyQ85891128
Eicosapentaenoic Acid combined with optimal statin therapy improves endothelial dysfunction in patients with coronary artery diseaseQ86585432
P433issue2
P921main subjectplaceboQ269829
phase I clinical trialQ5452194
P304page(s)177-187
P577publication date2017-06-09
P1433published inClinical pharmacology in drug developmentQ27726600
P1476titleSafety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega-3-Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single-Blind, Randomized, Placebo-Controlled Trial.
P478volume7

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Q96610645Pharmacokinetics of Single and Multiple Doses of Omega-3 Carboxylic Acids in Healthy Chinese Subjects: A Phase I, Open-Label Studycites workP2860

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