Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
1期
已完成
NCT04176224
| 适应症 | Japanese Patients With ALS |
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| 分期 | 1期 |
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| 申办方 | Shionogi |
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| 状态 | 已完成 |
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| 受试者人数 | 9 人 |
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| 干预（药物） | MT-1186 |
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| 开始日期 | 2019年4月17日 |
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| 完成日期 | 2019年9月4日 |
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| 结果公布日 | 2024年1月24日 |
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摘要
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
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, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. · ng·h/mL
| MT-1186 | 1719 ± 808 ng·h/mL |
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Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. · ng/mL
| MT-1186 | 1903 ± 978.5 ng/mL |
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Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. · h
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。