Trials / Completed
CompletedNCT02875080
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-34712 |
Timeline
- Start date
- 2016-09-27
- Primary completion
- 2016-11-27
- Completion
- 2016-11-27
- First posted
- 2016-08-23
- Last updated
- 2021-02-23
- Results posted
- 2021-02-23
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02875080. Inclusion in this directory is not an endorsement.