Bioequivalence, AUC, Cmax, PharmacokineticsPhase 1NCT01921920

Prilosec Bioequivalence Study in Healthy Volunteers

A Phase 1 study testing Omeprazole in people with Bioequivalence, AUC, Cmax, Pharmacokinetics, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence, AUC, Cmax, Pharmacokinetics
What is being tested?: Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Nov 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Overland Park, Kansas

Other trials in United States

About this study

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

Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Being tested: Omeprazole
Keywords: Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmeprazoleDrug
Also called Prilosec
Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)

Study groups in NCT01921920
Study group	Role	What they receive
Omeprazole 20mg aqueous	Active comparator	Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test) Receives: Drug: Omeprazole
Omeprazole 20mg organic	Active comparator	Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A) Receives: Drug: Omeprazole
Omeprazole 40mg aqueous	Active comparator	Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test) Receives: Drug: Omeprazole
Omeprazole 40mg organic	Active comparator	Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C) Receives: Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
AUC
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
AUC
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
AUC (0-t)
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
Cmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
AUC(0-t)
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
Cmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.

Secondary outcomes (12)

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
Cmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
Cmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
t1/2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
tmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
AUC(0-t)
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
AUC
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole
λz
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
tmax
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
AUC(0-t)
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
AUC
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
λz
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole
t1/2
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Nov 2013

First posted14 Aug 2013 (estimated)
Study startAug 2013
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bioequivalence, AUC, Cmax, PharmacokineticsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01921920
Sponsor's protocol ID: D9584C00010
Status last verified: Nov 2013
First submitted: 5 Aug 2013
Last updated: 25 Nov 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01921920
Acronym / sponsor ID: D9584C00010
Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Keywords: Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Omeprazole 20mg aqueous	Active comparator	Drug: OmeprazoleTreatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 20mg organic	Active comparator	Drug: OmeprazoleTreatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)
Omeprazole 40mg aqueous	Active comparator	Drug: OmeprazoleTreatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 40mg organic	Active comparator	Drug: OmeprazoleTreatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmeprazoleAlso: PrilosecOmeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)	Drug	Omeprazole 20mg aqueous, Omeprazole 20mg organic, Omeprazole 40mg aqueous, Omeprazole 40mg organic

Primary outcome

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

12 secondary outcomes

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Mathews, MD principal investigator

Quintiles Phase I unit, Kansas

Helen Lunde, MD study director

AstraZeneca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omeprazole in people with Bioequivalence, AUC, Cmax, Pharmacokinetics, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01921920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.