Trials / Completed
CompletedNCT03399734
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Perampanel | Single oral dose of 1 x 4-mg perampanel tablet |
| DRUG | Perampanel | Single 4-mg dose of perampanel fine granules |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2018-03-09
- Completion
- 2018-03-09
- First posted
- 2018-01-16
- Last updated
- 2018-10-29
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03399734. Inclusion in this directory is not an endorsement.