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

Eisai

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: E3810

Drug: Aciphex (rabeprazole)

Drug: Nexium (esomeprazole)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01153659

E3810-A001-038

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion:

Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)

Key Exclusion:

Subjects who are H. pylori-positive
Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
Other standard clinical pharmacology exclusion criteria for healthy volunteers