Articles with "japanese subjects" as a keyword



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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

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Published in 2018 at "Clinical Pharmacology in Drug Development"

DOI: 10.1002/cpdd.360

Abstract: OM3‐CA (omega‐3‐carboxylic acids) is a complex mixture of omega‐3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its… read more here.

Keywords: placebo; omega carboxylic; safety tolerability; japanese subjects ... See more keywords
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Letter to the Editor concerning “Normative values for the spine shape parameters using 3D standing analysis from a database of 268 asymptomatic Caucasian and Japanese subjects” by JC Le Huec et al. Eur Spine J (2016) 25:3630–3637

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Published in 2017 at "European Spine Journal"

DOI: 10.1007/s00586-017-5235-z

Abstract: With interest I read the article by Le Huec and Hasegawa [1] describing a meticulous study in which they used EOS low-dose full spine X-rays (EOS Imaging, Paris, France) to provide 3D information about standing… read more here.

Keywords: hip; lumbar lordosis; caucasian japanese; japanese subjects ... See more keywords
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Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study

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Published in 2018 at "Clinical Drug Investigation"

DOI: 10.1007/s40261-018-0687-4

Abstract: Background and ObjectivesEvocalcet is a novel calcimimetic agent with potential to improve the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. This study aimed to determine the pharmacokinetics, pharmacodynamics, and safety of evocalcet… read more here.

Keywords: evocalcet healthy; evocalcet; safety; study ... See more keywords
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Genetic variants of flavin-containing monooxygenase 3 (FMO3) derived from Japanese subjects with the trimethylaminuria phenotype and whole-genome sequence data from a large Japanese database.

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Published in 2019 at "Drug metabolism and pharmacokinetics"

DOI: 10.1016/j.dmpk.2019.06.001

Abstract: Flavin-containing monooxygenase 3 (FMO3) is a polymorphic xenobiotic- and dietary compound-metabolizing enzyme associated with the genetic disorder trimethylaminuria. We phenotyped 428 Japanese subjects using traditional urinary phenotyping assays and identified two subjects with read more here.

Keywords: containing monooxygenase; flavin containing; monooxygenase fmo3; database ... See more keywords
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Pharmacokinetics and safety of rilpivirine in healthy Japanese subjects and exploration of ethnic sensitivity of rilpivirine pharmacokinetics with physiologically based pharmacokinetic model approach.

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Published in 2021 at "Drug metabolism and pharmacokinetics"

DOI: 10.1016/j.dmpk.2021.100422

Abstract: Rilpivirine is a non-nucleoside reverse transcriptase inhibitor, used for the treatment of human immunodeficiency virus type-1 infection. An open label study was conducted to investigate the pharmacokinetics (PK) and safety of a single oral dose… read more here.

Keywords: rilpivirine; physiologically based; model; pharmacokinetics safety ... See more keywords
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Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects.

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Published in 2019 at "Dermatologic Surgery"

DOI: 10.1097/dss.0000000000002143

Abstract: BACKGROUND OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. OBJECTIVE To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese… read more here.

Keywords: treatment; japanese subjects; onabotulinumtoxina treatment; safety efficacy ... See more keywords

Effect of CSL112 (apolipoprotein A‐I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross‐study comparison

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Published in 2022 at "Clinical and Translational Science"

DOI: 10.1111/cts.13361

Abstract: CSL112 (apolipoprotein A‐I [apoA‐I, human]) is a novel drug in development to reduce the risk of recurrent cardiovascular events following acute myocardial infarction by increasing cholesterol efflux capacity (CEC). This phase I study aimed to… read more here.

Keywords: csl112; efflux capacity; cholesterol efflux; japanese subjects ... See more keywords
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FRI0411 SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS IN HEALTHY MALE JAPANESE SUBJECTS OF THE ADAMTS-5 INHIBITOR S201086/GLPG1972, A POTENTIAL NEW TREATMENT IN OA

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Published in 2020 at "Annals of the Rheumatic Diseases"

DOI: 10.1136/annrheumdis-2020-eular.744

Abstract: Background: The disintegrin and metalloproteinase with thrombospondin motifs-5 (ADAMTS-5) is a key enzyme in OA (Verma P, et al. J Cell Biochem 2011;112:3507-14). In preclinical models of OA, S201086, a potent and selective ADAMTS-5 inhibitor,… read more here.

Keywords: recherches internationales; institut recherches; employee institut; internationales servier ... See more keywords
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Field Study on Nationality Differences in Thermal Comfort of University Students in Dormitories during Winter in Japan

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Published in 2019 at "Buildings"

DOI: 10.3390/buildings9100213

Abstract: Comfort in university dormitory buildings in Japan is under-investigated as compared to offices and residences. A winter field survey conducted in two university dormitories in Central Japan aimed at investigating the differences in thermal responses… read more here.

Keywords: comfort university; nationality; university; differences thermal ... See more keywords
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Comparison of Weight Reduction, Change in Parameters and Safety of a Very Low Carbohydrate Diet in Comparison to a Low Carbohydrate Diet in Obese Japanese Subjects with Metabolic Disorders

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Published in 2023 at "Nutrients"

DOI: 10.3390/nu15061342

Abstract: Recently, low-carbohydrate diets (LCDs) have gained worldwide attention. LCDs are potentially effective for Japanese overweight and obese individuals with metabolic disorders. However, few randomized trials of LCDs have focused on the difference between LCDs and… read more here.

Keywords: carbohydrate diet; low carbohydrate; carbohydrate; japanese subjects ... See more keywords
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Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects

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Published in 2019 at "International Journal of Clinical Pharmacology and Therapeutics"

DOI: 10.5414/cp203418

Abstract: Objective: Bococizumab, a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, has been shown to reduce low-density lipoprotein cholesterol (LDL-C). Here, we describe the pharmacokinetics and pharmacodynamics of bococizumab and its effect on lipoprotein particle… read more here.

Keywords: pharmacokinetics exploratory; efficacy biomarkers; monoclonal antibody; exploratory efficacy ... See more keywords