HealthyPhase 1NCT01085708
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
A Phase 1 study testing rabeprazole in people with Healthy, run by Eisai Co., Ltd..
Trial summary
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2010
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19
Who cannot join
- Subjects with allergy
About this study
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.
- Conditions
- Healthy
- Being tested
- rabeprazole
- Keywords
- Rabeprazole, Japan, healthy Japanese male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
10 mg normal tablet
rabeprazoleDrug
Type 1 granule containing rabeprazole 10 mg
rabeprazoleDrug
Type 2 granules containing rabeprazole 10 mg
rabeprazoleDrug
Type 3 granules containing rabeprazole 10 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: rabeprazole |
| 2 | Experimental | Not described Receives: Drug: rabeprazole |
| 3 | Experimental | Not described Receives: Drug: rabeprazole |
| 4 | Active comparator | Not described Receives: Drug: rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Shibata, Study director, Clinical Research Center, Eisai, Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085708
- Sponsor's protocol ID
- E3810-J081-034
- Status last verified
- Sep 2010
- First submitted
- 11 Mar 2010
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
- ClinicalTrials.gov ID
- NCT01085708
- Acronym / sponsor ID
- E3810-J081-034
- Conditions
- Healthy
- Keywords
- Rabeprazole, Japan, healthy Japanese male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Mar 2010 (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.
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rabeprazole |
| 2 | Experimental | Drug: rabeprazole |
| 3 | Experimental | Drug: rabeprazole |
| 4 | Active comparator | Drug: rabeprazole |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19
Key exclusion criteria (1 listed)
- Subjects with allergy
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 |
|---|---|---|
| rabeprazole10 mg normal tablet | Drug | 1 |
| rabeprazoleType 1 granule containing rabeprazole 10 mg | Drug | 2 |
| rabeprazoleType 2 granules containing rabeprazole 10 mg | Drug | 3 |
| rabeprazoleType 3 granules containing rabeprazole 10 mg | Drug | 4 |
Primary outcome
The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
Time frame: One day
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 13 May 2013.
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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.
Kai Shibata study director
Clinical Research Center, Eisai, Co., Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rabeprazole in people with Healthy, run by Eisai Co., Ltd..
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 1 inclusion and 1 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 13 May 2013. 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?
The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) (time frame: One day). 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 13 May 2013.