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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fesoterodine ER (fasted)
* Drug: Fesoterodine SR3 (fasted)
* Drug: Fesoterodine SR3 (fed)
* Drug: Fesoterodine ER (fed)
* Drug: Fesoterodine SR3 (sprinkle)
* Drug: Fesoterodine ER (fasted)
* Drug: Fesoterodine SR4 (fasted)
* Drug: Fesoterodine SR4 (fed)
* Drug: Fesoterodine ER (fed)
* Drug: Fesoterodine SR4 (sprinkle)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: Fesoterodine ER (fasted)<br>* Commercial Fesoterodine ER 4 mg (single dose)<br>Drug: Fesoterodine SR3 (fasted)<br>* Fesoterodine SR3 4 mg (single dose)<br>Drug: Fesoterodine SR3 (fed)<br>* Fesoterodine SR3 4 mg (single dose) with high-fat meal<br>Drug: Fesoterodine ER (fed)<br>* Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal<br>Drug: Fesoterodine SR3 (sprinkle)<br>* Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce<br>|
| Experimental: Cohort 2<br> | Drug: Fesoterodine ER (fasted)<br>* Commercial Fesoterodine ER 4 mg (single dose)<br>Drug: Fesoterodine SR4 (fasted)<br>* Fesoterodine SR4 4 mg (single dose)<br>Drug: Fesoterodine SR4 (fed)<br>* Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal<br>Drug: Fesoterodine ER (fed)<br>* Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal<br>Drug: Fesoterodine SR4 (sprinkle)<br>* Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sprinkle, SR3, Fesoterodine, SR4, bioavailability, pharmacokinetics, applesauce