drugset / Trial / 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

NCT01153659

Phase 1 Completed 90 enrolled Eisai Inc.
Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2010-07
Primary completion
2010-08
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg Oral
Comparator Rabeprazole Small molecule 20 mg Oral
Comparator Rabeprazole Small molecule 50 mg Oral

Indications

No indication recorded.