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

Pfizer20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

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

Interventions

fesoterodineDRUG

single dose of beads in capsule

fesoterodineDRUG

single dose of beads in capsule

fesoterodineDRUG

single dose of beads in capsule

fesoterodine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Secondary Outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Data from ClinicalTrials.gov

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