drugset / Trial / NCT02020486
A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water
Timeline
- Start
- 2013-12
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perampanel | Small molecule | 4 mg | Oral |
| Subject | Perampanel | Small molecule | 6 mg | Oral |
Indications
No indication recorded.