Prilosec Bioequivalence Study in Healthy Volunteers

Overview

This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck

Full Title of Study: “An Open-label, Randomized, Single-center, 4-way Crossover, Single Dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous Solvent Based Capsules Manufactured by AstraZeneca With Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • Drug: Omeprazole
    • Omeprazole 20 mg (AstraZeneca – test) Omeprazole 40 mg (AstraZeneca – test) Omeprazole 20 (Merck – reference) Omeprazole 40mg (Merck – reference)

Arms, Groups and Cohorts

  • Active Comparator: Omeprazole 20mg aqueous
    • Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca – test)
  • Active Comparator: Omeprazole 20mg organic
    • Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck – reference for Treatment A)
  • Active Comparator: Omeprazole 40mg aqueous
    • Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca – test)
  • Active Comparator: Omeprazole 40mg organic
    • Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck – reference for Treatment C)

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC
  • Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC
  • Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC (0-t)
  • Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • Cmax
  • Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC(0-t)
  • Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • Cmax

Secondary Measures

  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • Cmax
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • Cmax
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • t1/2
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • tmax
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC(0-t)
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • λz
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • tmax
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC(0-t)
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • AUC
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • λz
  • Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
    • Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
    • t1/2

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture.
  • Female could be of nonchildbearing potential (postmenopausal or irreversible surgical sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).
  • Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at least 50 kg and no more than 100 kg, inclusive.

Exclusion Criteria

  • History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
  • Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
  • Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in tobacco-containing products).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Mathews, MD, Principal Investigator, Quintiles Phase I unit, Kansas
    • Helen Lunde, MD, Study Director, AstraZeneca

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