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NCT00786240 Clinical Trial

Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Healthy Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00786240
Other study ID # A0221063
Secondary ID
Status Completed
Phase Phase 1
First received November 5, 2008
Last updated September 8, 2010
Start date January 2009
Est. completion date February 2009

Study information
Verified date September 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Science Authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male or female Chinese or Japanese subjects

Exclusion Criteria:

- Evidence or history of clinically significant findings at screening

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fesoterodine
Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
• Fesoterodine
Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary 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 No
Secondary 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 No
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