Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Intervention: Esomeprazole 20 mg Delayed-Release Capsules; Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)
Intervention description: Esomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration.; Esomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration.
Intervention MeSH terms: Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate bioequivalence parameters of esomeprazole capsules
      20 mg (test product) vs. esomeprazole capsules 20 mg (reference product) under fasted
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document indicating that
             the participant has been informed of all pertinent aspects of the study before any
             assessment is performed.

          -  Participant who is willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Healthy Participant, which is defined as in general good physical health, as judged by
             the investigator and no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and pulse rate
             measurement, 12-lead electrocardiogram (ECG) or clinical laboratory tests.

          -  Body Mass Index (BMI) of 18.5 to 30.0 Kilogram per square meter (kg/m^2); and a total
             body weight Greater than or equal to (>=) 50.0 kg for males and >=45.0 kg for females.

          -  Participant with two negative tests (one at screening within 72 hours of admission and
             one at check on Day-1) for active COVID-19, separated by Greater Than (>) 24 hours.

          -  Female participant of childbearing potential and at risk for pregnancy must agree to
             use a highly effective method of contraception throughout the study and for at least
             30 days after the last dose of assigned treatment. Female participants who are not of
             childbearing potential must meet requirements in the Contraception section of
             protocol.

        Exclusion Criteria:

          -  Participant who is an investigational site staff member directly involved in the
             conduct of the study and his/her family members, site staff member otherwise
             supervised by the investigator, or participant who is a GSK employee directly involved
             in the conduct of the study.

          -  Participation in other studies involving investigational drug(s) within 30 days prior
             to study entry and/or during study participation.

          -  Acute or chronic medical or psychiatric condition or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Pregnant female participant.

          -  Breastfeeding female participant.

          -  Known or suspected intolerance or hypersensitivity or photosensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  Diagnosis of long QT syndrome or QTc > 450 Millisecond (msec) for males and > 470 msec
             for females.

          -  Clinically significant vital sign abnormalities (systolic blood pressure lower than 90
             or over 140 Millimeter of mercury (mmHg), diastolic blood pressure lower than 50 or
             over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute (bpm).

          -  A participant unwilling or unable to comply with Lifestyle Considerations described in
             this protocol.

          -  Use of any medication (including over-the-counter medications and herbal remedies)
             within 2 weeks before first scheduled study drug administration or within less than 10
             times the elimination half-life of the respective drug (whichever is longer), or is
             anticipated to require any concomitant medication during that period or at any time
             throughout the study. Allowed treatments are:

               -  systemic contraceptives and hormone replacement therapy, as long as female
                  participant is on stable treatment for at least 3 months before first scheduled
                  study drug administration and continues treatment throughout the study;

               -  occasional use of acetaminophen (up to 2 g daily).

          -  Evidence or history of clinically significant laboratory abnormality, hematological,
             renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease within the last 5 years that may increase the risk associated with
             study participation.

          -  Clinically relevant chronic or acute infectious illnesses or febrile infections within
             two weeks prior to start of the study.

          -  Participant with signs and symptoms suggestive of COVID-19 (i.e. fever, cough, etc)*
             within 14 days of inpatient admission. *as defined by WHO or local guidance)

          -  Participant with known COVID-19 positive contacts in the past 14 days.

          -  Any vaccination, including COVID-19 vaccine, within 14 days prior to the first dose.

          -  Any surgical or medical condition which may significantly alter the absorption,
             distribution, metabolism or excretion of any drug substance but not limited to any of
             the following:

               -  History of major gastrointestinal tract surgery such as gastrectomy,
                  gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric
                  banding (note: this is not applicable for minor abdominal surgery without
                  significant tissue resection, e.g., appendectomy and herniorrhaphy);

               -  History of inflammatory bowel disease;

               -  History or current evidence of renal disease or impaired renal function at
                  screening as indicated by abnormal levels of serum creatinine (> 123 micromole
                  per liter [μmol/L] for males and > 95 μmol/L for females) or blood urea nitrogen
                  (BUN) (>= 12.0 millimoles per liter [mmol/L]) or the presence of clinically
                  significant abnormal urinary constituents (e.g. albuminuria);

               -  History or current evidence of ongoing hepatic disease or impaired hepatic
                  function at screening. A candidate will be excluded if more than one of the
                  following lab value deviations are found: 1) aspartate transaminase (AST) (>= 1.2
                  upper limit of normal [ULN]), alanine transaminase [ALT] (>= 1.2 ULN), 2)
                  gamma-glutamyl transpeptidase (GGT) (>= 1.2 ULN), alkaline phosphatase (ALP) (>=
                  1.2 ULN), 3) bilirubin (>= 48 μmol/L for males and >= 30 μmol/L for females) or
                  creatine kinase (CK) (>= 3 ULN). A single deviation from the above values is
                  acceptable and will not exclude the candidate, unless specifically advised by the
                  investigator;

               -  Evidence of urinary obstruction or difficulty in voiding at screening;

               -  History or clinical evidence at screening of pancreatic injury or pancreatitis.

          -  Participant has a history of drug abuse or investigator has evidence of current drug
             abuse with drug classes that include but are not limited to barbiturates, tricyclic
             antidepressants, amphetamines, benzodiazepines, cocaine, opiates, cannabis or any
             other drugs (verified by urine drug screen or other reliable evidence).

          -  Evidence, as reported by an alcohol breath testing, for current alcohol abuse or
             reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of
             pure alcohol per day, i.e. 1 drink/day for women or 2 drinks/day for men (1 drink =
             150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of
             screening.

          -  Participant reported regular consumption of > 5 cups of coffee or tea per day (or
             equivalent consumption of >= 500 mg xanthine per day using other products)

          -  Smoker, defined as the use of tobacco or nicotine products during the 3 months prior
             to screening until admission to the unit or a positive urine cotinine test at
             screening.

          -  A participant who is unwilling to abstain from tobacco or nicotine-containing product
             use during the study.

          -  Participant reports consumption of any drug metabolizing enzyme (e.g. cytochrome P450
             [CYP]3A4 or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages
             or food supplements (e.g. broccoli, Brussels sprouts, grapefruit, grapefruit juice,
             star fruit, St. John's Wort etc.) within 2 weeks prior to screening until admission to
             the unit.

          -  Positive results in any of the virology tests for human immunodeficiency virus (HIV)
             antigen and antibody, hepatitis C virus antibody (HCV Ab), hepatitis B surface antigen
             (HbsAg), and hepatitis B core antibody (HBcAb) ([immunoglobulin G] IgG +
             immunoglobulin M [IgM]).

          -  Performance of unaccustomed strenuous physical exercise (body building, high
             performance sports) from 2 weeks prior to admission and throughout the entire study.

          -  Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate
             substitutions cannot be applied or in the investigator's opinion may pose a risk to
             the candidate.

          -  Any condition not identified in the protocol that in the opinion of the investigator
             would confound the evaluation and interpretation of the study data or may put the
             participant at risk

          -  Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
             volume drawn at screening) of 50 milliliter (mL) to 499 mL of blood within 30 days, or
             more than 499 mL within 56 days prior to the first dose.

          -  Participant who has previously been enrolled in this study.