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Prilosec Bioequivalence Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01921920
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bioequivalence, AUC, Cmax, Pharmacokinetics Drug: Omeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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 Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omeprazole 20mg aqueous
Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)
Drug: Omeprazole
Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
Other Name: Prilosec

Active Comparator: Omeprazole 20mg organic
Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)
Drug: Omeprazole
Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
Other Name: Prilosec

Active Comparator: Omeprazole 40mg aqueous
Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)
Drug: Omeprazole
Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
Other Name: Prilosec

Active Comparator: Omeprazole 40mg organic
Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)
Drug: Omeprazole
Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
Other Name: Prilosec




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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)

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921920


Locations
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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: David Mathews, MD Quintiles Phase I unit, Kansas
Study Director: Helen Lunde, MD AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01921920     History of Changes
Other Study ID Numbers: D9584C00010
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by AstraZeneca:
Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence

Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action