Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
第1相
完了
NCT00102479
| 対象疾患 | Schizophrenia, Mania |
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| 相 | 第1相 |
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| スポンサー | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 21 名 |
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| 介入（薬剤） | Aripiprazole |
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| 開始日 | 2004年7月1日 |
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| 完了日 | 2005年7月1日 |
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| 結果公開日 | 2026年6月22日 |
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概要
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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