Treatment of Overactive Bladder Clinical Trial
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.
NCT number | NCT00902681 |
Other study ID # | A0221082 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | August 2009 |
Verified date | September 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCinf, AUClast, and Cmax of 5-HMT | 6 weeks | ||
Secondary | Tmax and half-life of 5-HMT as data permit. | 6 weeks | ||
Secondary | Safety laboratory tests and adverse events | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00902187 -
A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
|
Phase 1 |