Therapeutic EquivalencyPhase 1NCT00807118
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
A Phase 1 study testing Fesoterodine in people with Therapeutic Equivalency and Food, run by Pfizer at 1 site in Japan.
Trial summary
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency, Food
- What is being tested?
- Fesoterodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2008to Dec 2008
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy male subject
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-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects.
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.
- Conditions
- Therapeutic Equivalency, Food
- Being tested
- Fesoterodine
- Keywords
- bioequivalence, food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Single dose of 2 x 4 mg tab in formulation F under fed condition
FesoterodineDrug
Single dose of 1 x 8 mg tab in formulation F under fed condition
FesoterodineDrug
Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
FesoterodineDrug
Single dose of 1 x 8 mg tab in formulation F under fed condition
FesoterodineDrug
Single dose of 2 x 4 mg tab in formulation F under fasted condition
FesoterodineDrug
Single dose of 1 x 8 mg tab in formulation F under fasted condition
| Study group | Role | What they receive |
|---|---|---|
| A (Cohort I) | Experimental | Not described Receives: Drug: Fesoterodine |
| B (Cohort I) | Experimental | Not described Receives: Drug: Fesoterodine |
| C (Cohort I) | Experimental | Not described Receives: Drug: Fesoterodine |
| B (Cohort II) | Experimental | Not described Receives: Drug: Fesoterodine |
| D (Cohort II) | Experimental | Not described Receives: Drug: Fesoterodine |
| E (Cohort II) | 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 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition
Measured: Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition
Measured: Day 1 and 2
AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)
Measured: Day 1 and 2
Secondary outcomes (2)
Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment
Measured: Day 1 and 2
AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II
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 posted11 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies 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
- 108 participants (estimated)
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
- NCT00807118
- Sponsor's protocol ID
- A0221052
- Status last verified
- Mar 2010
- First submitted
- 10 Dec 2008
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 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-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00807118
- Acronym / sponsor ID
- A0221052
- Conditions
- Therapeutic Equivalency, Food
- Keywords
- bioequivalence, food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Dec 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.
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A (Cohort I) | Experimental | Drug: Fesoterodine |
| B (Cohort I) | Experimental | Drug: Fesoterodine |
| C (Cohort I) | Experimental | Drug: Fesoterodine |
| B (Cohort II) | Experimental | Drug: Fesoterodine |
| D (Cohort II) | Experimental | Drug: Fesoterodine |
| E (Cohort II) | Experimental | Drug: Fesoterodine |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Japanese healthy male subject
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 2 x 4 mg tab in formulation F under fed condition | Drug | A (Cohort I) |
| FesoterodineSingle dose of 1 x 8 mg tab in formulation F under fed condition | Drug | B (Cohort I) |
| FesoterodineSingle dose of 1 x 8 mg tab in formulation E(1) under fed condition | Drug | C (Cohort I) |
| FesoterodineSingle dose of 1 x 8 mg tab in formulation F under fed condition | Drug | B (Cohort II) |
| FesoterodineSingle dose of 2 x 4 mg tab in formulation F under fasted condition | Drug | D (Cohort II) |
| FesoterodineSingle dose of 1 x 8 mg tab in formulation F under fasted condition | Drug | E (Cohort II) |
Primary outcome
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition
Time frame: Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition
Time frame: Day 1 and 2
AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)
Time frame: Day 1 and 2
2 secondary outcomes
Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment
Time frame: Day 1 and 2
AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II
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 24 Mar 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 Therapeutic Equivalency and Food, run by Pfizer at 1 site in Japan.
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 24 Mar 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 Japan. 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 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition (time frame: Day 1 and 2). The study lists 3 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 24 Mar 2010.