Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

• Published in: Clinical pharmacology in drug development Vol. 10; no. 10; pp. 1188 - 1197
• Main Authors: Shimizu, Hidetoshi, Nishimura, Yukiko, Shiide, Youichi, Yoshida, Kaori, Hirai, Manabu, Matsuda, Munetomo, Nakamaru, Yoshinobu, Kato, Yuichiro, Kondo, Kazuoki
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.10.2021; John Wiley and Sons Inc
• Subjects: Administration, Oral; Adolescent; Adult; ALS; Amyotrophic lateral sclerosis; Bioequivalence; bioequivalence study; clinical pharmacology; Cross-Over Studies; Drug Compounding - methods; edaravone; Edaravone - administration & dosage; Edaravone - metabolism; Female; Free Radical Scavengers - administration & dosage; Free Radical Scavengers - metabolism; Healthy Volunteers; Humans; Infusions, Intravenous; Male; Metabolites; oral formulation; Original Manuscript; Plasma; Suspensions; Therapeutic Equivalency; Young Adult; ALS; clinical pharmacology; edaravone; bioequivalence study; oral formulation; amyotrophic lateral sclerosis
• ISSN: 2160-763X; 2160-7648; 2160-7648
• DOI: 10.1002/cpdd.952

The neuroprotective agent edaravone is an intravenous treatment for amyotrophic lateral sclerosis. As intravenous administration burdens patients, orally administered treatments are needed. This phase 1, open‐label, single‐dose crossover study in 42 healthy adults evaluated bioequivalence of a 105‐m...