An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment

• Published in: Clinical therapeutics Vol. 42; no. 9; pp. 1699 - 1714
• Main Authors: Nakamaru, Yoshinobu, Kakubari, Masae, Yoshida, Kaori, Akimoto, Makoto, Kondo, Kazuoki
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2020; Elsevier Limited
• Subjects: Adult; Aged; Alcohol; Amyotrophic lateral sclerosis; Antigens; Area Under Curve; Bilirubin; Biochemistry; Birth control; Complications; Cytochrome; Disease; Dosage; Drug dosages; edaravone; Edaravone - administration & dosage; Edaravone - pharmacokinetics; FDA approval; Female; Food; Glomerular Filtration Rate; Headache; Hematology; Hepatitis; Humans; Internal Medicine; Intravenous administration; Japan; Japanese; Male; Medical Education; Medical laboratories; Metabolites; Middle Aged; Pharmacokinetics; Plasma; Renal function; renal impairment; Renal Insufficiency - physiopathology; Statistical analysis; Sulfates; Urinalysis; Urine; Vital signs; Vomiting; Japan; United States > US; pharmacokinetics; edaravone; Japanese; renal impairment

The goal of this study was to compare edaravone pharmacokinetic (PK) variables and tolerability after a single intravenous (IV) infusion of 30 mg over 60 min in subjects with mild renal impairment (estimated glomerular filtration rate 60–89 mL/min/1.73 m2), moderate renal impairment (30–59 mL/min/1....