NCT00902681

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

May 14, 2009

Last Update Submit

September 26, 2018

Conditions

Treatment of Overactive Bladder

Keywords

Bioequivalence, Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • AUCinf, AUClast, and Cmax of 5-HMT

    6 weeks

Secondary Outcomes (2)

  • Tmax and half-life of 5-HMT as data permit.

    6 weeks

  • Safety laboratory tests and adverse events

    6 weeks

Study Arms (2)

Reference

OTHER

a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau

Drug: Fesoterodine

Test

OTHER

a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)

Drug: Fesoterodine

Interventions

FesoterodineDRUG

A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg

Also known as: Toviaz 8 mg
Reference

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

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
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

US(1)