Treatment of Overactive BladderPhase 1NCT00902187
A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
A Phase 1 study testing Fesoterodine in people with Treatment of Overactive Bladder, run by Pfizer at 1 site in United States.
Trial summary
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Overactive Bladder
- 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Subjects with evidence or history of clinically significant urologic diseases
- A positive urine drug screen
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.
- Conditions
- Treatment of Overactive Bladder
- Being tested
- Fesoterodine
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Also called Toviaz 4 mg
A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
FesoterodineDrug
Also called Toviaz 4 mg
A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Reference | Other | fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference) Receives: Drug: Fesoterodine |
| Test | Other | fesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test) Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf, AUClast, and Cmax of 5-HMT
Measured: 6 weeks
Secondary outcomes (2)
Tmax and half-life of 5-HMT as data permit
Measured: 6 weeks
Safety laboratory tests and adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Overactive BladderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00902187
- Sponsor's protocol ID
- A0221081
- Status last verified
- Oct 2018
- First submitted
- 14 May 2009
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00902187
- Acronym / sponsor ID
- A0221081
- Conditions
- Treatment of Overactive Bladder
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 May 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.
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Other | Drug: Fesoterodinefesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference) |
| Test | Other | Drug: Fesoterodinefesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Subjects with evidence or history of clinically significant urologic diseases
- A positive urine drug screen
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method
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 |
|---|---|---|
| FesoterodineAlso: Toviaz 4 mgA fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg | Drug | Reference |
| FesoterodineAlso: Toviaz 4 mgA fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg | Drug | Test |
Primary outcome
AUCinf, AUClast, and Cmax of 5-HMT
Time frame: 6 weeks
2 secondary outcomes
Tmax and half-life of 5-HMT as data permit
Time frame: 6 weeks
Safety laboratory tests and adverse events
Time frame: 6 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 16 Oct 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Treatment of Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
RecruitingPhase 2
RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
Overactive Bladder (OAB)
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 Treatment of Overactive Bladder, run by Pfizer at 1 site in United States.
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 3 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 16 Oct 2018. 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 United States. 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?
AUCinf, AUClast, and Cmax of 5-HMT (time frame: 6 weeks). 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 16 Oct 2018.