We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396577
First Posted: July 19, 2011
Last Update Posted: May 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
July 13, 2011
July 19, 2011
May 4, 2012
December 2010
March 2011   (Final data collection date for primary outcome measure)
  • Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test), [ Time Frame: 8 days ]
  • AUC(0-t) of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) [ Time Frame: 8 days ]
  • AUC(0-inf) of 6 x 2-mg perampanel tablets (ref) compared to that of the 12-mg perampanel tablet (test) [ Time Frame: 8 days ]
Same as current
Complete list of historical versions of study NCT01396577 on ClinicalTrials.gov Archive Site
The incidence of AEs [ Time Frame: 8 days ]
Same as current
Not Provided
Not Provided
 
Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects
A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects
The purpose of this study is to determine that three 2-mg tablets of perampanel are bioequivalent to one 6-mg tablet of perampanel.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: perampanel
    3 x 2 mg perampanel once per day
  • Drug: perampanel
    6 mg perampanel once per day
  • Active Comparator: 3 x 2-mg perampanel
    Intervention: Drug: perampanel
  • Active Comparator: 6mg perampanel
    Intervention: Drug: perampanel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion:

  1. Healthy male or female subjects, age 18 to 55 years old, inclusive, at Screening
  2. Body mass index (BMI) of 18 to 32 kg/m^2, inclusive, at Screening

Exclusion:

  1. Subjects who are taking any prescribed or over-the-counter drug or herbal remedies in the 2 weeks prior to Screening (unless the OTC drug has a long halflife [i.e., 5 x 1/2 greater than 2 weeks]) with the exception of acetaminophen (up to 4 g/day), which is allowed up to 12 hours prior to dosing
  2. Subjects who have taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
  3. Subjects who have taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, apple or Seville orange products)
  4. Subjects who have received any experimental drug within the 12 weeks leading up to the start of study drug treatment or who are currently enrolled in another clinical trial
  5. Subjects with a known or suspected history of alcohol abuse within the 6 months prior to Screening or who have a positive urine drug test or breath alcohol test at Screening or Baseline, or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement
  6. Subjects who consume more than 5 caffeinated beverages per day (e.g., 5 cups of tea, coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the periods of in-patient confinement
  7. Subjects who smoke more than 5 cigarettes (or equivalent amount of tobacco) per day or who are unwilling to abstain from the use of nicotine-containing products throughout the period of in-patient confinement
  8. Subjects who have a history of drug abuse or dependence or have a positive result from a urine drug screening test
  9. Women of child-bearing potential who do not agree to use 2 methods of adequate contraception (e.g., intrauterine device, barrier methods with spermicide) throughout the study and for 30 days after study drug administration
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01396577
E2007-A001-039
Not Provided
Not Provided
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Robert Cooper Eisai Medical Services
Eisai Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP