Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Condition: Human Experimentation
Intervention: Zegerid; Prevacid®
Intervention description: Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.; Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.
Intervention MeSH terms: Omeprazole; Lansoprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine differences between Proton Pump Inhibitors (PPI) formulations
      relative to their effects on gastric acidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy non-Asian, male or non-lactating, non-pregnant female participants who are
             18-65 years of age.

          -  Clinical laboratory test must be within normal limits or clinically acceptable to the
             Investigator/Sponsor.

          -  Participants must have normal or clinically acceptable physical exam and ECG.

          -  Participants must be free of any clinically significant disease that requires a
             physician's care and/or would interfere with study evaluations, procedures, or
             participation.

          -  Able to understand and comply with study procedures required and able and willing to
             provide written informed consent prior to any study procedures being performed.

        Exclusion Criteria:

          -  History of hypersensitivity, allergy or intolerance to omeprazole, or other proton
             pump inhibitors

          -  History of peptic ulcer disease or other acid related gastrointestinal symptoms or
             heartburn with a frequency of more than one/month.

          -  Positive H. pylori breath test at screening.

          -  Participation in any study of an investigational treatment in the 30 days before
             Screening or participation in another study at any time during the period of this
             study

          -  Any significant medical illness that would contraindicate participation in the study

          -  Gastrointestinal disorder or surgery leading to impaired drug absorption

          -  Any significant mental illness, such as schizophrenia or bipolar disorder

          -  History (in the past year) suggestive of alcohol or drug abuse or dependence, or
             excessive alcohol use (>2 units per day on average; for example >2 bottles of beer, >2
             glasses of wine, >2 ounces of liquor/spirits), or excessive alcohol use during the
             study

          -  Any abnormal Screening laboratory value that is clinically significant in the
             investigator's opinion

          -  Currently using or use of any prescription or over the counter (OTC) medications that
             affect gastrointestinal function, including first generation antihistamines (e.g.
             diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment
             administration.

          -  Currently using, or use within 14 days of first treatment administration, or having a
             history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists,
             or OTC or Rx use of proton pump inhibitors.

          -  Positive urine drug/alcohol test at Screening.