NCT01153659

A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets

A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	E3810	RAB ER 50 mg capsule once per day on Days 1-5
DRUG	Aciphex (rabeprazole)	Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
DRUG	Nexium (esomeprazole)	Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-10-01
• First posted: 2010-06-30
• Last updated: 2013-11-01

Locations

1 site across 1 country: United States