Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02160158

Enrollment

Registered

2014-06-10

Start date

2014-07-31

Completion date

2014-12-31

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Fesoterodine, SR3, SR4, bioavailability, pharmacokinetics, sprinkle, applesauce

Brief summary

The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).

Interventions

DRUGFesoterodine ER (fasted)

Commercial Fesoterodine ER 4 mg (single dose)

DRUGFesoterodine SR3 (fasted)

Fesoterodine SR3 4 mg (single dose)

DRUGFesoterodine SR3 (fed)

Fesoterodine SR3 4 mg (single dose) with high-fat meal

DRUGFesoterodine ER (fed)

Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

DRUGFesoterodine SR3 (sprinkle)

Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce

DRUGFesoterodine SR4 (fasted)

Fesoterodine SR4 4 mg (single dose)

DRUGFesoterodine SR4 (fed)

Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal

DRUGFesoterodine SR4 (sprinkle)

Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion criteria

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication * History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon * Evidence or history of clinically significant urologic disease \[urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	48 hours	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)	48 hours	—

Secondary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	48 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	48 hours	—
Plasma Decay Half-Life (t1/2)	48 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026