Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

第1相 完了 NCT04254913

概要

To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy

Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone

Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. · ng·h/mL

Maximum Plasma Concentration (Cmax) of Unchanged Edaravone

Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. · ng/mL

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone

Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. · h

BENITIONS で見る ClinicalTrials.gov の原文を見る

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• Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis — Shionogi
• Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS — Shionogi

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