Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
- Registration Number
- NCT01085695
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.
- Detailed Description
The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 rabeprazole - 2 rabeprazole - 3 rabeprazole - 4 rabeprazole -
- Primary Outcome Measures
Name Time Method The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) One day
- Secondary Outcome Measures
Name Time Method Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring 13 days