This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency

Treatments: Drug: fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01286454

A0221068

Details and patient eligibility

About

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Full description

To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion criteria

• Evidence or history of clinically significant disease

Trial design

20 participants in 6 patient groups

A

Experimental group

Description:

4 mg fesoterodine IR beads in capsule under fasting condition

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

B

Experimental group

Description:

4 mg fesoterodine 10% coated ER beads in capsule under fasting condition

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

C

Experimental group

Description:

4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

D

Experimental group

Description:

4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

E

Experimental group

Description:

4 mg fesoterodine ER tablets under fasting condition.

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

F

Experimental group

Description:

4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.

Treatment:

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine

Drug: fesoterodine