drugset / Trial / NCT03854409
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder
Phase 1
Completed
72 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collabPRA Health Sciences · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2019-01-31
- Primary completion
- 2019-04-05
- Completion
- 2020-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 420 mg | Intramuscular |