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NCT03854409 · ClinicalTrials.gov registry record · Phase 1
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT03854409: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03854409 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854409, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2020-02-20 |
| Phase | Phase 1 |
What the finished NCT03854409 record still lists
NCT03854409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT03854409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03854409 about?
NCT03854409 is a clinical study titled "A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder". The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.
What is the current status of trial NCT03854409?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2019-01-31. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT03854409?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT03854409?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03854409's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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