An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Background and Objectives YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. An open-label, crossover, pha...

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Bibliographic Details
Published in:	European journal of drug metabolism and pharmacokinetics Vol. 45; no. 4; pp. 467 - 475
Main Authors:	Shennak, Mustafa, Al-Jaouni, Rana, Kshirasagar, Santhosh, Kasibhatta, Ravi Sekhar, Godse, Neelima, Al-Ghazawi, Ahmad, Vittala, Praveen, Bakhle, Dhananjay
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01-08-2020
Subjects:	Adult Biological Availability Biomedical and Life Sciences Biomedicine Biosimilar Pharmaceuticals - administration & dosage Biosimilar Pharmaceuticals - adverse effects Biosimilar Pharmaceuticals - pharmacokinetics Cross-Over Studies Drug Monitoring Etanercept - administration & dosage Etanercept - adverse effects Etanercept - pharmacokinetics Healthy Volunteers Human Physiology Humans Injections, Subcutaneous Jordan Male Medical Biochemistry Middle Aged Original Original Research Article Pharmaceutical Sciences/Technology Pharmacology/Toxicology Pharmacy Therapeutic Equivalency Tumor Necrosis Factor Inhibitors - administration & dosage Tumor Necrosis Factor Inhibitors - adverse effects Tumor Necrosis Factor Inhibitors - pharmacokinetics Young Adult Jordan
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