HeartburnPhase 1NCT01337804
A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12)
A Phase 1 study testing omeprazole/sodium bicarbonate and omeprazole magnesium in people with Heartburn, run by Bayer.
Trial summary
This study compares the bioequivalence of omeprazole administered as either Zegerid® powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heartburn
- What is being tested?
- omeprazole/sodium bicarbonate and omeprazole magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is of non-Asian origin.
- Female participants of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at the screening visit, throughout the study, and until 2 weeks after the last dose of study drug.
- Participant has a Body Mass Index (BMI) ≤35 kg/m2 at the screening visit.
- Participant is judged to be in good health.
- Participant has no clinically significant abnormality on electrocardiogram (ECG).
- Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months.
Who cannot join
- Participant is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
- Participant has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Participant has taken any gastric antisecretory drugs (e.g., histamine receptor type-2 antagonists [H2RAs] or proton pump inhibitors [PPIs]), antacids, or any other prescription or over- the-counter (OTC) medications within 14 days prior to Period 1 and during the trial.
- Participant has been treated with any trial drug or therapy, or participated in a clinical trial in the 30 days prior to Period 1.
- Participant has any laboratory test result prior to dosing in Period 1 deviating from the normal reference ranges established by the local laboratory by more than 20% that the investigator judges to be of possible clinical significance.
- Participant has an estimated creatinine clearance of ≤80 mL/min based on the Cockcroft-Gault equation.
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- Participant has a history of stroke, chronic seizures, or major neurological disorder.
- Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Participants with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator.
- Participant has a history of neoplastic disease.
- Participant is a nursing mother.
- Participant has any history or serologic evidence of hepatitis B or C with abnormal liver function tests (except for benign, self-limited hepatitis A >5 years prior to randomization), hepatic or biliary tract disease, or a history of gastrointestinal tract surgery.
- Participant has an allergy or hypersensitivity to any component/excipient of the study drugs, has a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
- Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort [hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the telephone follow-up. There may be certain medications that are permitted. Participants must be explicitly warned of the potential risk of taking erythromycin, clarithromycin, nefazodone, ketoconazole, itraconazole, cyclosporine, and human immunodeficiency virus (HIV)protease inhibitors during the study.
- Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses per day of alcoholic beverages (1 glass is approximately equivalent to: 10 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits).
- Participant has consumed grapefruit juice, grapefruits and grapefruit products within 2 weeks prior to administration of the initial dose of study drug, and does not agree to refrain from their consumption throughout the study (including the washout interval between treatment periods) and until the telephone follow-up.
- Participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, chocolate, or other caffeinated beverages per day.
- Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 30 days prior to Period 1. The 4-week window will be derived from the date of the last study procedure (i.e., telephone follow-up) in the previous study to the screening visit of the current study.
- Participant is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
- There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study.
About this study
Official title: A Single Dose, Comparative, Open-label, Randomized, Crossover Bioequivalence Study of Omeprazole Administered as Zegerid® Powder for Oral Suspension 20 mg and Prilosec 40 mg Capsule in Healthy Subjects
This study compares the bioequivalence of omeprazole administered as either Zegerid® powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.
- Conditions
- Heartburn
- Being tested
- omeprazole/sodium bicarbonate, omeprazole magnesium
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazole/sodium bicarbonateDrug
Also called Zegerid Powder for Oral Suspension
Single 20 mg dose of omeprazole/sodium bicarbonate powder for oral suspension
omeprazole magnesiumDrug
Also called Prilosec
Single 40 mg capsule of omeprazole given orally
| Study group | Role | What they receive |
|---|---|---|
| Zegerid-Prilosec | Experimental | Participants receive Zegerid in Period 1 and Prilosec in Period 2, with a 10- to 21-day washout between study drug administrations. Receives: Drug: omeprazole/sodium bicarbonate; Drug: omeprazole magnesium |
| Prilosec-Zegerid | Experimental | Participants receive Prilosec in Period 1 and Zegerid in Period 2, with a 10- to 21-day washout between study drug administrations. Receives: Drug: omeprazole/sodium bicarbonate; Drug: omeprazole magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from 0 to infinity (AUC[0-∞])
Measured: Up to 12 hours post-dose
Maximum plasma concentration (Cmax)
Measured: Up to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337804
- Sponsor's protocol ID
- 18136
- Other IDs
- P08050
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Comparative, Open-label, Randomized, Crossover Bioequivalence Study of Omeprazole Administered as Zegerid® Powder for Oral Suspension 20 mg and Prilosec 40 mg Capsule in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01337804
- Acronym / sponsor ID
- 18136
- Conditions
- Heartburn
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Apr 2011 (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.
This study compares the bioequivalence of omeprazole administered as either Zegerid® powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zegerid-Prilosec | Experimental | Drug: omeprazole/sodium bicarbonate, Drug: omeprazole magnesiumParticipants receive Zegerid in Period 1 and Prilosec in Period 2, with a 10- to 21-day washout between study drug administrations. |
| Prilosec-Zegerid | Experimental | Drug: omeprazole/sodium bicarbonate, Drug: omeprazole magnesiumParticipants receive Prilosec in Period 1 and Zegerid in Period 2, with a 10- to 21-day washout between study drug administrations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant is of non-Asian origin.
- Female participants of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at the screening visit, throughout the study, and until 2 weeks after the last dose of study drug.
- Participant has a Body Mass Index (BMI) ≤35 kg/m2 at the screening visit.
- Participant is judged to be in good health.
- Participant has no clinically significant abnormality on electrocardiogram (ECG).
Key exclusion criteria (19 listed)
- Participant is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
- Participant has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Participant has taken any gastric antisecretory drugs (e.g., histamine receptor type-2 antagonists [H2RAs] or proton pump inhibitors [PPIs]), antacids, or any other prescription or over- the-counter (OTC) medications within 14 days prior to Period 1 and during the trial.
- Participant has been treated with any trial drug or therapy, or participated in a clinical trial in the 30 days prior to Period 1.
- Participant has any laboratory test result prior to dosing in Period 1 deviating from the normal reference ranges established by the local laboratory by more than 20% that the investigator judges to be of possible clinical significance.
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 |
|---|---|---|
| omeprazole/sodium bicarbonateAlso: Zegerid Powder for Oral SuspensionSingle 20 mg dose of omeprazole/sodium bicarbonate powder for oral suspension | Drug | Prilosec-Zegerid, Zegerid-Prilosec |
| omeprazole magnesiumAlso: PrilosecSingle 40 mg capsule of omeprazole given orally | Drug | Prilosec-Zegerid, Zegerid-Prilosec |
Primary outcome
Area under the plasma concentration-time curve from 0 to infinity (AUC[0-∞])
Time frame: Up to 12 hours post-dose
Maximum plasma concentration (Cmax)
Time frame: Up to 12 hours post-dose
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 23 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing omeprazole/sodium bicarbonate and omeprazole magnesium in people with Heartburn, run by Bayer.
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 6 inclusion and 19 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under the plasma concentration-time curve from 0 to infinity (AUC[0-∞]) (time frame: Up to 12 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.