Phase 1 Completed N=20 Randomized

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

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

Source: ClinicalTrials.gov NCT01286454 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2012

Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT]) — 30.48; 28.24; 19.64; NA ng*hr/mL

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])	30.48; 28.24; 19.64; NA; 27.40; 32.07	—
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)	30.23; 27.79; 17.92; 7.59; 26.80; 31.88	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)	5.830; 3.030; 1.092; 0.323; 2.247; 5.183	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)	1.0; 6.0; 6.0; 8.0; 5.0; 4.0	—
SECONDARY Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)	5.56; 7.22; 10.89; NA; 7.54; 4.59	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.