Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

Exclusion Criteria

• •BMI \> 40
• •Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based on CYP2C19 genotyping test.
• •Any significant history of / or concurrent gastrointestinal diseases or conditions such as:
• •* GERD
• •* Acute gastrointestinal bleeding
• •* Zollinger Ellison Syndrome or Gastric hypersecretory condition
• •* Known Barrett's esophagus
• •* Esophageal stricture
• •* Peptic ulcer disease (gastric or duodenal) or family history of peptic ulcer disease
• •* Gastric outlet obstruction
• •* Gastroparesis
• •Significant medical history or concurrent illness as determined by the principal investigator
• •Any medical disorder that alters the normal gastric acid secretion profile as determined by the principal investigator
• •History of diabetes mellitus
• •Significant laboratory abnormalities as determined by the principal investigator
• •Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, respiratory alkalosis
• •Pregnant or lactating women
• •Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial
• •Use of any medication other than contraception or hormone replacement therapy; OTC drugs other than vitamins or occasional acetaminophen within 30 days prior to entering the trial or during the trial
• •Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen, Aspirin, Naproxen etc)
• •Positive urine test for alcohol or other drugs
• •Concurrent use of gastric anti-secretory drugs such as defined below:
• •* Use of a PPI 30 days prior to each stage or during the trial
• •* Use of H2RA 14 days prior to each stage or during the trial
• •* Concurrent use of antacids (including over-the-counter) 24 hours prior to each stage or during the trial
• •Use of any medication that modifies gastric acid secretion 30 days prior to or during the trial.
• •Had ingested grapefruit within 14 days of dose administration in any trial period
• •Significant drug allergy or known hypersensitivity to any of the ingredients in the trial drugs Omeprazole, Succinic Acid or to Lidocaine
• •Consumption of coffee within 48 hours of dose administration in any trial period.
• •Had donated blood within 30 days of entering the trial
• •Known positive serology for HBV, HCV or HIV
• •Any reason which makes the subject a poor candidate based on the physician's discretion