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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01240187
First received: September 23, 2010
Last updated: May 13, 2013
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Partial Onset Epilepsy
 Drug: perampanel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 Drug: perampanel
Single dose of 6 tablets 2 mg orally
Experimental: Experimental 2 Drug: perampanel
Single dose of 1 tablet 12 mg orally

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240187

Locations
United Kingdom
Quotient Clinical
Edinburgh, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Dr Joanne Collier Quotient Clinical
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01240187     History of Changes
Other Study ID Numbers: E2007-E044-037
Study First Received: September 23, 2010
Last Updated: May 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eisai Inc.:
epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013