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NCT01921920

Prilosec Bioequivalence Study in Healthy Volunteers

NCT ID: NCT01921920

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Bioequivalence, AUC, Cmax, Pharmacokinetics

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Omeprazole 20mg aqueous

Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

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

Omeprazole 20mg organic

Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

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

Omeprazole 40mg aqueous

Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

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

Omeprazole 40mg organic

Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

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

Interventions

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Omeprazole

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

Intervention Type DRUG

Other Intervention Names

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Prilosec

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase I unit, Kansas

Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D9584C00010

Identifier Type: -

Identifier Source: org_study_id