Trials / Completed
CompletedNCT03285503
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Otsuka Beijing Research Institute · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
Detailed description
To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole IM Depot | administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia. |
Timeline
- Start date
- 2018-08-17
- Primary completion
- 2019-10-14
- Completion
- 2019-10-14
- First posted
- 2017-09-18
- Last updated
- 2020-07-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03285503. Inclusion in this directory is not an endorsement.