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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