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Clinical Trials/NCT00786240
NCT00786240
Completed
Phase 1

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.

Pfizer1 site in 1 country37 target enrollmentJanuary 2009
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ConditionsHealthy
InterventionsFesoterodine
DrugsFesoterodine

Overview

Phase
Phase 1
Intervention
Fesoterodine
Conditions
Healthy
Sponsor
Pfizer
Enrollment
37
Locations
1
Primary Endpoint
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
February 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

Inclusion Criteria

  • •Healthy male or female Chinese or Japanese subjects

Exclusion Criteria

  • •Evidence or history of clinically significant findings at screening

Arms & Interventions

A

Intervention: Fesoterodine

B

Intervention: Fesoterodine

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Day 1 and 2

Secondary Outcomes

  • 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 Sites (1)

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