Conditions: Gastric Acid Human Experimentation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule arm 2: Omeprazole magnesium 20 mg OTC tablet

Interventions: intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium (20 mg equivalent)
Intervention descriptions: intervention 1: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days. intervention 2: Single dose of omeprazole magnesium per day for either 1 or 7 days.

Protocol document: