Status:
COMPLETED
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Lead Sponsor:
Eisai Inc.
Conditions:
Partial Onset Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01240187
Start Date
June 1 2010
End Date
September 1 2010
Last Update
May 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical
Edinburgh, United Kingdom