Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
1期
已完成
NCT00102479
| 适应症 | Schizophrenia, Mania |
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| 分期 | 1期 |
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| 申办方 | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 21 人 |
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| 干预（药物） | Aripiprazole |
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| 开始日期 | 2004年7月1日 |
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| 完成日期 | 2005年7月1日 |
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| 结果公布日 | 2026年6月22日 |
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摘要
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
Percentage of Participants Able to Tolerate Maximum Dose Level
14 Days · Percentage of Participants
| Aripiprazole 20 mg | 83 Percentage of Participants |
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| Aripiprazole 25 mg | 80 Percentage of Participants |
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| Aripiprazole 30 mg | 100 Percentage of Participants |
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Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
57 days · participants
| Aripiprazole 20 mg | 8 participants |
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| Aripiprazole 25 mg | 7 participants |
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| Aripiprazole 30 mg | 6 participants |
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| Aripiprazole 20 mg | 0 participants |
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| Aripiprazole 25 mg | 0 participants |
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| Aripiprazole 30 mg | 0 participants |
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Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Pre-dose and 1 to 24 hours post-dose on Day 14 · ng/mL
| Aripiprazole 20 mg | 435 ± 137 ng/mL |
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| Aripiprazole 25 mg | 529 ± 341 ng/mL |
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| Aripiprazole 30 mg | 653 ± 213 ng/mL |
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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。