Healthy SubjectsPhase 1NCT00383916
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
A Phase 1 study testing pantoprazole in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
A study comparing 2 different investigational formulations of pantoprazole in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- pantoprazole
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2006
- 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
- Men or women aged 18 to 50 years.
- Healthy as determined by the investigator.
Who cannot join
- History or active presence of clinically important medical disease.
- History of drug or alcohol abuse.
About this study
Official title: An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects.
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
Read the detailed description
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study
- Conditions
- Healthy Subjects
- Being tested
- pantoprazole
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
Secondary outcomes (1)
To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383916
- Sponsor's protocol ID
- 3001B1-119
- Status last verified
- Mar 2007
- First submitted
- 2 Oct 2006
- Last updated
- 8 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00383916
- Acronym / sponsor ID
- 3001B1-119
- Conditions
- Healthy Subjects
- Keywords
- healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Oct 2006
- First posted
- 4 Oct 2006 (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.
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
Detailed description
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men or women aged 18 to 50 years.
- Healthy as determined by the investigator.
Key exclusion criteria (2 listed)
- History or active presence of clinically important medical disease.
- History of drug or alcohol abuse.
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 |
|---|---|---|
| pantoprazole | Drug | – |
Primary outcome
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
1 secondary outcome
To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.
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 8 Mar 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pantoprazole in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 2 inclusion and 2 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 8 Mar 2007. 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?
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.. 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 8 Mar 2007.