A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rabeprazole sodium, 5 mg Tablets
* Drug: Rabeprazole sodium, 10 mg Tablets
* Drug: Rabeprazole sodium, 20 mg Tablets
* Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adult Japanese male between the age of 20-40 body mass index between 18.5-25 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rabeprazole sodium Tablets, 5 mg<br> | Drug: Rabeprazole sodium, 5 mg Tablets<br>* Rabeprazole sodium Tablets, 5 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.<br>* Other names: E3810, E3810-J081-040;|
| Experimental: Rabeprazole sodium Tablets, 10 mg<br> | Drug: Rabeprazole sodium, 10 mg Tablets<br>* Rabeprazole sodium Tablets, 10 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.<br>* Other names: E3810, E3810-J081-040;|
| Experimental: Rabeprazole sodium Tablets, 20 mg<br> | Drug: Rabeprazole sodium, 20 mg Tablets<br>* Rabeprazole sodium Tablets, 20 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.<br>* Other names: E3810, E3810-J081-040;|
| Experimental: Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets)<br> | Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)<br>* Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast.<br>* Other names: E3810, E3810-J081-040;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration | 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. | Day 5 of administration during Period I-IV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) | 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. | Day 1 and Day 5 of administration during Period I-IV | 
| Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabeprazole, proton pump inhibitor, pharmacokinetics, pharmacodynamics, healthy adult male Japanese subjects