Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

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Detailed Description

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Conditions

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Normal Healthy Subject Population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Zegerid®

Group Type ACTIVE_COMPARATOR

Zegerid®

Intervention Type DRUG

capsule(20 mg omeprazole/sodium bicarbonate), single dose

2

Prilosec OTC®

Group Type EXPERIMENTAL

Prilosec OTC®

Intervention Type DRUG

Omeprazole-magnesium 20.6 mg, tablet, single dose

Interventions

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Zegerid®

capsule(20 mg omeprazole/sodium bicarbonate), single dose

Intervention Type DRUG

Prilosec OTC®

Omeprazole-magnesium 20.6 mg, tablet, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal subjects who are 18-65 years of age;
* Non-childbearing potential females or those using birth control

Exclusion Criteria

* History of significant GI disease
* Any significant medical illness
* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
* Currently using GI medications
* GI disorder or surgery leading to impaired drug absorption

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes