Phase1, Single Dose, Crossover Study to Determine Bioequivalence

A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00786240

Enrollment

Registered

2008-11-06

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2010-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioequivalence, Therapeutic Equivalency

Brief summary

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

Interventions

DRUGFesoterodine

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female Chinese or Japanese subjects

Exclusion criteria

* Evidence or history of clinically significant findings at screening

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026