A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Eisai

Status and phase: Completed; Phase 1

Conditions: Partial Onset Epilepsy

Treatments: Drug: perampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240187

E2007-E044-037

Details and patient eligibility

About

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.

Full description

A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Experimental 1

Experimental group

Treatment:

Drug: perampanel

Drug: perampanel

Experimental 2

Experimental group

Treatment:

Drug: perampanel

Drug: perampanel