Trials / Completed
CompletedNCT02362412
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Study of FK949E - An Open-label, Two-way Crossover Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK949E | A tablet containing 50 mg or 150 mg of quetiapine taken orally. |
Timeline
- Start date
- 2015-02-18
- Primary completion
- 2016-02-06
- Completion
- 2016-02-06
- First posted
- 2015-02-12
- Last updated
- 2024-11-15
- Results posted
- 2017-03-17
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02362412. Inclusion in this directory is not an endorsement.