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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
RAB ER 50 mg capsule once per day on Days 1-5
Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Percentage of time that intragastric pH remains >4
Time frame: 24-hr period post-dose on Day 5
Percentage of day- and night-time periods with intragastric pH >4
Time frame: Days 1 and 5
Number and duration of nocturnal acid breakthrough (NAB) episodes
Time frame: Days 1 and 5
Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
Time frame: Days 1 and 5
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