Back to resultsA Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Primary Purpose
Treatment of Overactive Bladder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fesoterodine
Fesoterodine
Sponsored by
About this trial
This is an interventional other trial for Treatment of Overactive Bladder focused on measuring Bioequivalence, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Healthy male and/or female subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria:
- 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Reference
Test
Arm Description
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
Outcomes
Primary Outcome Measures
AUCinf, AUClast, and Cmax of 5-HMT
Secondary Outcome Measures
Tmax and half-life of 5-HMT as data permit.
Safety laboratory tests and adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00902681
Brief Title
A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Official Title
An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Overactive Bladder
Keywords
Bioequivalence, Pharmacokinetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reference
Arm Type
Other
Arm Description
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau
Arm Title
Test
Arm Type
Other
Arm Description
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Other Intervention Name(s)
Toviaz 8 mg
Intervention Description
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Other Intervention Name(s)
Toviaz 8 mg
Intervention Description
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Primary Outcome Measure Information:
Title
AUCinf, AUClast, and Cmax of 5-HMT
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Tmax and half-life of 5-HMT as data permit.
Time Frame
6 weeks
Title
Safety laboratory tests and adverse events
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and/or female subjects
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221082
Description
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A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
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