NCT01202071

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rabeprazole sodium, 5 mg Tablets	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.
DRUG	Rabeprazole sodium, 10 mg Tablets	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.
DRUG	Rabeprazole sodium, 20 mg Tablets	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.
DRUG	Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)	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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-09-15
• Last updated: 2012-11-30
• Results posted: 2012-11-27

Locations

1 site across 1 country: Japan