Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
Phase 1
Completed
NCT00102479
| Condition | Schizophrenia, Mania |
|---|
| Phase | Phase 1 |
|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 21 participants |
|---|
| Interventions | Aripiprazole |
|---|
| Start date | Jul 1, 2004 |
|---|
| Completion date | Jul 1, 2005 |
|---|
| Results posted | Jun 22, 2026 |
|---|
Summary
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 |
|---|
| Aripiprazole 25 mg | 80 Percentage of Participants |
|---|
| Aripiprazole 30 mg | 100 Percentage of Participants |
|---|
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 |
|---|
| Aripiprazole 25 mg | 7 participants |
|---|
| Aripiprazole 30 mg | 6 participants |
|---|
| Aripiprazole 20 mg | 0 participants |
|---|
| Aripiprazole 25 mg | 0 participants |
|---|
| Aripiprazole 30 mg | 0 participants |
|---|
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 |
|---|
| Aripiprazole 25 mg | 529 ± 341 ng/mL |
|---|
| Aripiprazole 30 mg | 653 ± 213 ng/mL |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.