NCT00786240

Brief Summary

The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

1 month

First QC Date

November 5, 2008

Last Update Submit

September 8, 2010

Conditions

Healthy

Keywords

BioequivalenceTherapeutic Equivalency

Outcome Measures

Primary Outcomes (2)

  • AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions

    Day 1 and 2

  • AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions

    Day 1 and 2

Secondary Outcomes (2)

  • Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions

    Day 1 and 2

  • Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions

    Day 1 and 2

Study Arms (2)

A

EXPERIMENTAL
Drug: Fesoterodine

B

EXPERIMENTAL
Drug: Fesoterodine

Interventions

FesoterodineDRUG

Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)

A

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female Chinese or Japanese subjects

You may not qualify if:

  • Evidence or history of clinically significant findings at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

fesoterodine

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations

SG(1)