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Phase 1 Completed N=55 Randomized Double-blind Other

Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants

Source: ClinicalTrials.gov NCT05265247 ↗
Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Maximum Observed Post Dose Concentration (Cmax) — 483; 514 Nanograms per milliliter

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Observed Post Dose Concentration (Cmax)
483; 514
PRIMARY
Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to the Last Measurable Sampling Time Point
772.10; 815.55
SECONDARY
Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC0-inf)
792.72; 800.94
SECONDARY
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)
0.34; 0.35
SECONDARY
Terminal Elimination Rate Constant
0.8839; 0.8504
SECONDARY
Time of the Maximum Observed Post-Dose Concentration (Tmax)
1.983; 1.983
SECONDARY
Elimination Half-Life (T1/2)
0.78; 0.82

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, et
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05265247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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