NCT00807118

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

December 10, 2008

Last Update Submit

March 23, 2010

Conditions

Therapeutic EquivalencyFood

Keywords

bioequivalence, food effect

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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)

    Day 1 and 2

Secondary Outcomes (2)

  • Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment

    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

    Day 1 and 2

Study Arms (6)

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

Interventions

FesoterodineDRUG

Single dose of 2 x 4 mg tab in formulation F under fed condition

A (Cohort I)

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese healthy male subject

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

Shinjuku-ku, Tokyo, Japan

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

December 10, 2008

First Posted

December 11, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations

JP(1)