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An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment
Highlights • Renal impairment did not significantly affect edaravone PK in Japanese patients. • Edaravone sulfate conjugate is a substrate for human organic anion transporters. • Reduced transporters may hypothetically increase sulfate conjugate levels. • Edaravone dosage adjustments may not be required in mild to moderate renal impairment.
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning
Highlights • Hepatic impairment had no effect on edaravone PK in Japanese and white subjects • There were no notable safety concerns with edaravone administration • Edaravone dosage adjustments are unlikely to be needed in hepatic impairment • Edaravone PK did not differ in Japanese and white subjects after IV administration Abstract Purpose Two studies were conducted to assess the pharmacokinetic (PK) properties and tolerability of edaravone in Japanese subjects with mild to moderate hepatic...
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