Prilosec Bioequivalence Study in Healthy Volunteers
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention: Omeprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): David Mathews, MD, Principal Investigator, Affiliation: Quintiles Phase I unit, Kansas Helen Lunde, MD, Study Director, Affiliation: AstraZeneca
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsulesBioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
Secondary outcome: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazolePharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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).
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
Starting date: August 2013
Last updated: November 21, 2013
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