A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01202071
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
- healthy adult Japanese male between the age of 20-40
- body mass index between 18.5-25
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
- use of any non-prescription medication within the previous 1 week
- history of drug or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rabeprazole sodium Tablets, 5 mg Rabeprazole sodium, 5 mg Tablets - Rabeprazole sodium Tablets, 10 mg Rabeprazole sodium, 10 mg Tablets - Rabeprazole sodium Tablets, 20 mg Rabeprazole sodium, 20 mg Tablets - Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets) -
- Primary Outcome Measures
Name Time Method Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration Day 5 of administration during Period I-IV The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Day 1 and Day 5 of administration during Period I-IV Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose) Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng\*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.