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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01153659

Enrollment

Registered

2010-06-30

Start date

2010-07-31

Completion date

2010-10-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

rabeprazole, esomeprazole, h. pylori-negative, nocturnal acid breakthrough, intragastric pH, PK/PD, effect on gastric pH in healthy, H. pylori-Negative subjects

Brief 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.

Interventions

DRUGE3810

RAB ER 50 mg capsule once per day on Days 1-5

DRUGAciphex (rabeprazole)

Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5

DRUGNexium (esomeprazole)

Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Percentage of time that intragastric pH remains >4	24-hr period post-dose on Day 5

Secondary

Measure	Time frame
Percentage of day- and night-time periods with intragastric pH >4	Days 1 and 5
Number and duration of nocturnal acid breakthrough (NAB) episodes	Days 1 and 5
Proportion of subjects with nocturnal acid breakthrough (NAB) episodes	Days 1 and 5

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026