Clinical trial NCT01921920: Prilosec Bioequivalence Study in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Keywords: Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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).

Primary outcomes:
measure: Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Secondary outcomes:
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
measure: Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
timeFrame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles Phase I unit, Kansas
name: David Mathews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Helen Lunde, MD
role: STUDY_DIRECTOR
References: