Healthy VolunteersPhase 1NCT00871806
Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
A Phase 1 study testing Commercial tablet with water, ODT #1 without water and ODT #2 without water in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
Trial summary
The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Commercial tablet with water, ODT #1 without water and ODT #2 without water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2009to Apr 2009
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- No CYP3A4 inhibitors
Who cannot join
- Clinically significant disease in any organ system
- Positive urine drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
- Conditions
- Healthy Volunteers
- Being tested
- Commercial tablet with water, ODT #1 without water, ODT #2 without water, ODT #1 with water, ODT #2 with water
- Keywords
- Pharmacokinetics, eletriptan, bioavailability, oral disintegrating tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial tablet with waterDrug
40 mg tablet, given once to each subject
ODT #1 without waterDrug
40 mg tablet given once to each subject
ODT #2 without waterDrug
40 mg tablet given once to each subject
ODT #1 with waterDrug
40 mg tablet given once to each subject
ODT #2 with waterDrug
40 mg tablet given once to each subject
| Study group | Role | What they receive |
|---|---|---|
| Eletriptan commercial tablet with water | Active comparator | Eletriptan commercial tablet given with water Receives: Drug: Commercial tablet with water |
| Eletriptan oral disintegrating tablet (ODT) #1 without water | Experimental | Oral disintegrating tablet formulation #1 without water Receives: Drug: ODT #1 without water |
| Oral disintegrating tablet formulation (ODT) #2 without water | Experimental | Oral disintegrating tablet formulation #2 without water Receives: Drug: ODT #2 without water |
| Oral disintegrating tablet formulation (ODT) #1 with water | Experimental | Oral disintegrating tablet formulation (ODT) #1 with water Receives: Drug: ODT #1 with water |
| Oral disintegrating tablet formulation (ODT) #2 with water | Experimental | Oral disintegrating tablet formulation (ODT) #2 with water Receives: Drug: ODT #2 with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
Measured: 24 hr
Secondary outcomes (2)
Time of peak eletriptan concentrations (Tmax), half life
Measured: 24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871806
- Sponsor's protocol ID
- A1601122
- Status last verified
- Jan 2021
- First submitted
- 26 Mar 2009
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
- ClinicalTrials.gov ID
- NCT00871806
- Acronym / sponsor ID
- A1601122
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, eletriptan, bioavailability, oral disintegrating tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Mar 2009 (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 study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eletriptan commercial tablet with water | Active comparator | Drug: Commercial tablet with waterEletriptan commercial tablet given with water |
| Eletriptan oral disintegrating tablet (ODT) #1 without water | Experimental | Drug: ODT #1 without waterOral disintegrating tablet formulation #1 without water |
| Oral disintegrating tablet formulation (ODT) #2 without water | Experimental | Drug: ODT #2 without waterOral disintegrating tablet formulation #2 without water |
| Oral disintegrating tablet formulation (ODT) #1 with water | Experimental | Drug: ODT #1 with waterOral disintegrating tablet formulation (ODT) #1 with water |
| Oral disintegrating tablet formulation (ODT) #2 with water | Experimental | Drug: ODT #2 with waterOral disintegrating tablet formulation (ODT) #2 with water |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- No CYP3A4 inhibitors
Key exclusion criteria (2 listed)
- Clinically significant disease in any organ system
- Positive urine drug screen
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 |
|---|---|---|
| Commercial tablet with water40 mg tablet, given once to each subject | Drug | Eletriptan commercial tablet with water |
| ODT #1 without water40 mg tablet given once to each subject | Drug | Eletriptan oral disintegrating tablet (ODT) #1 without water |
| ODT #2 without water40 mg tablet given once to each subject | Drug | Oral disintegrating tablet formulation (ODT) #2 without water |
| ODT #1 with water40 mg tablet given once to each subject | Drug | Oral disintegrating tablet formulation (ODT) #1 with water |
| ODT #2 with water40 mg tablet given once to each subject | Drug | Oral disintegrating tablet formulation (ODT) #2 with water |
Primary outcome
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
Time frame: 24 hr
2 secondary outcomes
Time of peak eletriptan concentrations (Tmax), half life
Time frame: 24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
Time frame: 3 weeks
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 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Commercial tablet with water, ODT #1 without water and ODT #2 without water in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
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 27 Jan 2021. 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 Singapore. 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?
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) (time frame: 24 hr). 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 27 Jan 2021.