Clinical trial: A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12) (NCT01337804)

Eligibility criteria:
Inclusion Criteria:

          -  Participant is of non-Asian origin.

          -  Female participants of reproductive potential must have a negative pregnancy test and
             agree to use (and/or have their partner use) two acceptable methods of birth control
             beginning at the screening visit, throughout the study, and until 2 weeks after the
             last dose of study drug.

          -  Participant has a Body Mass Index (BMI) ≤35 kg/m2 at the screening visit.

          -  Participant is judged to be in good health.

          -  Participant has no clinically significant abnormality on electrocardiogram (ECG).

          -  Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing
             products for at least 6 months.

        Exclusion Criteria:

          -  Participant is mentally or legally incapacitated, has significant emotional problems
             at the time of screening visit or has a history of a clinically significant
             psychiatric disorder over the last 5 to 10 years. Participants who have had
             situational depression may be enrolled in the study at the discretion of the
             investigator.

          -  Participant has a history of any illness that, in the opinion of the study
             investigator, might confound the results of the study or poses an additional risk to
             the participant by their participation in the study.

          -  Participant has taken any gastric antisecretory drugs (e.g., histamine receptor type-2
             antagonists [H2RAs] or proton pump inhibitors [PPIs]), antacids, or any other
             prescription or over- the-counter (OTC) medications within 14 days prior to Period 1
             and during the trial.

          -  Participant has been treated with any trial drug or therapy, or participated in a
             clinical trial in the 30 days prior to Period 1.

          -  Participant has any laboratory test result prior to dosing in Period 1 deviating from
             the normal reference ranges established by the local laboratory by more than 20% that
             the investigator judges to be of possible clinical significance.

          -  Participant has an estimated creatinine clearance of ≤80 mL/min based on the
             Cockcroft-Gault equation.

          -  Participant has a history of stroke, chronic seizures, or major neurological disorder.

          -  Participant has a history of clinically significant endocrine, gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
             genitourinary abnormalities or diseases. Participants with a history of uncomplicated
             kidney stones or childhood asthma may be enrolled in the study at the discretion of
             the investigator.

          -  Participant has a history of neoplastic disease.

          -  Participant is a nursing mother.

          -  Participant has any history or serologic evidence of hepatitis B or C with abnormal
             liver function tests (except for benign, self-limited hepatitis A >5 years prior to
             randomization), hepatic or biliary tract disease, or a history of gastrointestinal
             tract surgery.

          -  Participant has an allergy or hypersensitivity to any component/excipient of the study
             drugs, has a history of significant multiple and/or severe allergies (including latex
             allergy), or has had an anaphylactic reaction or significant intolerability to
             prescription or non-prescription drugs or food.

          -  Participant is unable to refrain from or anticipates the use of any medication,
             including prescription and non-prescription drugs or herbal remedies (such as St.
             John's Wort [hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives)
             prior to administration of the initial dose of study drug, throughout the study
             (including washout intervals between treatment periods), until the telephone
             follow-up. There may be certain medications that are permitted. Participants must be
             explicitly warned of the potential risk of taking erythromycin, clarithromycin,
             nefazodone, ketoconazole, itraconazole, cyclosporine, and human immunodeficiency virus
             (HIV)protease inhibitors during the study.

          -  Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses
             per day of alcoholic beverages (1 glass is approximately equivalent to: 10 ounces of
             beer, 4 ounces of wine, or 1 ounce of distilled spirits).

          -  Participant has consumed grapefruit juice, grapefruits and grapefruit products within
             2 weeks prior to administration of the initial dose of study drug, and does not agree
             to refrain from their consumption throughout the study (including the washout interval
             between treatment periods) and until the telephone follow-up.

          -  Participant consumes excessive amounts, defined as greater than 6 servings (1 serving
             is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, chocolate, or
             other caffeinated beverages per day.

          -  Participant has had major surgery, donated or lost 1 unit of blood (approximately 500
             mL) or participated in another investigational study within 30 days prior to Period 1.
             The 4-week window will be derived from the date of the last study procedure (i.e.,
             telephone follow-up) in the previous study to the screening visit of the current
             study.

          -  Participant is currently a regular user (including "recreational use") of any illicit
             drugs or has a history of drug (including alcohol) abuse within approximately 1 year.

          -  There is any concern by the investigator regarding the safe participation of the
             participant in the study or for any other reason; the investigator considers the
             participant inappropriate for participation in the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction