Human Experimentation Clinical Trial
Official title:
Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a single-dose, 2-way crossover design. These
participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules,
and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order,
with a minimum of a 2-week washout period between treatment legs. This group underwent a
24-hour intragastric pH study on each of the 2 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7
days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with
the prior group, there was a minimum of a 2-week washout period between treatment legs.
Participants assigned to this treatment group underwent 24-hour intragastric pH recordings
on the days which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a
24-hour baseline intragastric pH study prior to starting their randomized treatments. This
study design enabled all 60 participants to be evaluated for effects of the first dose of
Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the
subsequent 24-hour period following the first dose.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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