Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Dexlansoprazole; Lansoprazole; Omeprazole; Omeprazole, sodium bicarbonate drug combination; Proton Pump Inhibitors

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.