HealthyPhase 1NCT00786240
Phase1, Single Dose, Crossover Study to Determine Bioequivalence
A Phase 1 study testing Fesoterodine in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1). Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2009to Feb 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 male or female Chinese or Japanese subjects
Who cannot join
- Evidence or history of clinically significant findings at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.
The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).
- Conditions
- Healthy
- Being tested
- Fesoterodine
- Keywords
- Bioequivalence, Therapeutic Equivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
FesoterodineDrug
Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Fesoterodine |
| B | Experimental | Not described Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
Measured: Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
Measured: Day 1 and 2
Secondary outcomes (2)
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
Measured: Day 1 and 2
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
Measured: Day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- More trials run by PfizerThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786240
- Sponsor's protocol ID
- A0221063
- Status last verified
- Sep 2010
- First submitted
- 5 Nov 2008
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00786240
- Acronym / sponsor ID
- A0221063
- Conditions
- Healthy
- Keywords
- Bioequivalence, Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 6 Nov 2008 (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 objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fesoterodine |
| B | Experimental | Drug: Fesoterodine |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female Chinese or Japanese subjects
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant findings at screening
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 |
|---|---|---|
| FesoterodineSingle dose of 4 mg tablet in formulation D under fasted conditions (Reference) | Drug | A |
| FesoterodineSingle dose of 4 mg tablet in formulation E(1) under fasted conditions (Test) | Drug | B |
Primary outcome
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
Time frame: Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
Time frame: Day 1 and 2
2 secondary outcomes
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
Time frame: Day 1 and 2
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
Time frame: Day 1 and 2
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 9 Sep 2010.
- 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 Fesoterodine in people with Healthy, run by Pfizer 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 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 9 Sep 2010. 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?
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions (time frame: Day 1 and 2). 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 9 Sep 2010.