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

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

Detailed Description
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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.

Official Title
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An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers

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

Intervention / Treatment
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* Drug: fesoterodine
* Drug: fesoterodine
* Drug: fesoterodine
* Drug: fesoterodine
* Drug: fesoterodine
* Drug: fesoterodine


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 Exclusion Criteria: Evidence or history of clinically significant disease

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>4 mg fesoterodine IR beads in capsule under fasting condition | Drug: fesoterodine<br>* single dose of beads in capsule<br>|
| Experimental: B<br>4 mg fesoterodine 10% coated ER beads in capsule under fasting condition | Drug: fesoterodine<br>* single dose of beads in capsule<br>|
| Experimental: C<br>4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. | Drug: fesoterodine<br>* single dose of beads in capsule<br>|
| Experimental: D<br>4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. | Drug: fesoterodine<br>* single dose of beads in capsule<br>|
| Experimental: E<br>4 mg fesoterodine ER tablets under fasting condition. | Drug: fesoterodine<br>* single dose of tablet<br>|
| Experimental: F<br>4 mg fesoterodine TBD % coated ER beads in capsule under fed condition. | Drug: fesoterodine<br>* single dose of beads in capsule<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 - ∞)] 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 - ∞). | 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. | 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) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT) |  | 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. | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BIOAVAILABILITY, FOOD EFFECT