A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
- Registration Number
- NCT01240187
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
- Detailed Description
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Healthy male or female subjects aged between 18-55 years.
- BMI of 18-32 kg/m ^2.
- Willing and able to provide written informed consent.
Exclusion criteria:
- Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
- Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
- Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
- Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
- Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
- Subjects who consume more than five caffeinated beverages per day.
- Subjects who smoke more than 5 cigarettes per day.
- Subjects with a history of drug abuse or who have a positive urine drug screening test.
- Women who do not agree to use two methods of contraception.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental 1 perampanel - Experimental 2 perampanel -
- Primary Outcome Measures
Name Time Method To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet. 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Clinical
🇬🇧Edinburgh, United Kingdom