Prilosec Bioequivalence Study in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01921920

Enrollment

Registered

2013-08-14

Start date

2013-08-31

Completion date

2013-11-30

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence, AUC, Cmax, Pharmacokinetics

Keywords

Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence

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

Interventions

DRUGOmeprazole

Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules	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	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	AUC

Secondary

Measure	Time frame	Description
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole	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	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	Cmax

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026