A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects
E2006
+ E2006
+ E2006
Mental Disorders+3
+ Nervous System Diseases
+ Sleep Wake Disorders
Treatment Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion: Healthy males or females, ages 18 to 55 years Body mass index (BMI) > 18 and 32 kg/m2 at Screening Exclusion: Female subjects who are nursing Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006 Subjects with a known history of clinically significant drug or food allergies Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Group III
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location