CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Rabeprazole sodium, 5 mg Tablets +3 moredrug
Likely dose
Rabeprazole sodium, 5 mg Tabletsfrom record
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Search/NCT01202071
NCT01202071Phase 2Completed
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A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers

Eisai Co., Ltd.·interventional·Posted Sep 15, 2010·Updated Nov 30, 2012

In Brief

A Phase 2 clinical trial evaluating Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets, and 2 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.8 years ago

Interventions

Rabeprazole sodium, 5 mg Tabletsdrug

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.

Rabeprazole sodium, 10 mg Tabletsdrug

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.

Rabeprazole sodium, 20 mg Tabletsdrug

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.

Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)drug

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.