search
Back to results

The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
warfarin
Warfarin plus Fesoterodine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Overactive Bladder Urgency Frequency

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Warfarin Alone

Warfarin Concomitantly With Fesoterodine

Arm Description

Reference treatment

Test treatment

Outcomes

Primary Outcome Measures

Cmax and AUCinf for both S- and R-warfarin
AUC_INR and INRmax

Secondary Outcome Measures

AUClast, Tmax and t½ for both S- and R-warfarin
AUC_PT and PTmax
Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.

Full Information

First Posted
June 3, 2009
Last Updated
May 31, 2011
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00914667
Brief Title
The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Official Title
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin In Healthy Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Overactive Bladder Urgency Frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Warfarin Alone
Arm Type
Experimental
Arm Description
Reference treatment
Arm Title
Warfarin Concomitantly With Fesoterodine
Arm Type
Experimental
Arm Description
Test treatment
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
Single Dose Warfarin 25 mg on Day 1
Intervention Type
Drug
Intervention Name(s)
Warfarin plus Fesoterodine
Intervention Description
Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3
Primary Outcome Measure Information:
Title
Cmax and AUCinf for both S- and R-warfarin
Time Frame
8 days per period
Title
AUC_INR and INRmax
Time Frame
8 days per period
Secondary Outcome Measure Information:
Title
AUClast, Tmax and t½ for both S- and R-warfarin
Time Frame
8 days per period
Title
AUC_PT and PTmax
Time Frame
8 days per period
Title
Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.
Time Frame
8 days per period

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 between the ages of 18 and 55 years Exclusion Criteria: Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality
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=A0221079&StudyName=The%20Effect%20Of%20Fesoterodine%20On%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20Warfarin%20In%20Healthy%20Subjects
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

We'll reach out to this number within 24 hrs