Trials / Completed
CompletedNCT03902574
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 39 Years
- Healthy volunteers
- Accepted
Summary
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole ODT 2mg with water | Brexpiprazole ODT 2mg is administered with water. |
| DRUG | Brexpiprazole ODT 2mg without water | Brexpiprazole ODT 2mg is administered without water. |
| DRUG | Brexpiprazole conventional tablet 2mg | Brexpiprazole conventional tablet 2mg is administered with water. |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2019-06-18
- Completion
- 2019-06-18
- First posted
- 2019-04-04
- Last updated
- 2021-07-20
- Results posted
- 2021-07-20
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03902574. Inclusion in this directory is not an endorsement.