Open AccessA randomized, crossover pharmacodynamic study of immediate‐release omeprazole/sodium bicarbonate and delayed‐release lansoprazole in healthy adult volunteers
Author(s) -
Pratha Vijayalakshmi S.,
McGraw Thomas,
Tobin William
Publication year - 2016
Publication title -
pharmacology research and perspectives
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.975
H-Index - 27
ISSN - 2052-1707
DOI - 10.1002/prp2.238
Subject(s) - lansoprazole , omeprazole , crossover study , onset of action , gastric acid , sodium bicarbonate , proton pump inhibitor , medicine , bioavailability , pharmacology , antacid , pharmacodynamics , gastroenterology , chemistry , pharmacokinetics , stomach , alternative medicine , pathology , placebo
Proton pump inhibitors ( PPI s) effectively block gastric acid secretion and are the treatment of choice for heartburn. PPI s differ, however, in onset of action and bioavailability. In this single‐center, open‐label, three‐way crossover study, onset of action of immediate‐release omeprazole 20 mg/sodium bicarbonate 1100 mg ( IR ‐ OME ) and delayed‐release ( DR ) lansoprazole 15 mg was evaluated in 63 healthy fasting adults. Subjects were randomized to once daily IR ‐ OME , or DR ‐lansoprazole, or no treatment for 7 days. The primary efficacy endpoint was the earliest time where a statistically significant difference was observed between IR ‐ OME and DR ‐lansoprazole in median intragastric pH scores for three consecutive 5‐min intervals on day 7. Secondary endpoints compared effects of active treatments on days 1 and 7 (e.g., time to sustained inhibition, percentage of time with pH >4). A significant difference in median intragastric pH favoring IR ‐ OME was observed on day 7 starting at the 10‐ to 15‐min interval postdosing ( P = 0.024) and sustaining through the 115‐ to 120‐min interval ( P = 0.017). On day 1, IR ‐ OME achieved sustained inhibition of intragastric acidity significantly faster than DR ‐lansoprazole. IR ‐ OME maintained pH >4 significantly longer than DR ‐lansoprazole over a 24‐h period ( P = 0.007) on day 7. Overall, results of this study demonstrate IR ‐ OME is safe and well tolerated and that treatment with IR ‐ OME results in significantly faster onset of action and better gastric acid suppression at steady state than DR ‐lansoprazole.