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
NCT ID: NCT02160158
Last Updated: 2015-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1
Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR3 (fasted)
Fesoterodine SR3 4 mg (single dose)
Fesoterodine SR3 (fed)
Fesoterodine SR3 4 mg (single dose) with high-fat meal
Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR3 (sprinkle)
Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
Cohort 2
Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR4 (fasted)
Fesoterodine SR4 4 mg (single dose)
Fesoterodine SR4 (fed)
Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR4 (sprinkle)
Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
Interventions
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Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR3 (fasted)
Fesoterodine SR3 4 mg (single dose)
Fesoterodine SR3 (fed)
Fesoterodine SR3 4 mg (single dose) with high-fat meal
Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR3 (sprinkle)
Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR4 (fasted)
Fesoterodine SR4 4 mg (single dose)
Fesoterodine SR4 (fed)
Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR4 (sprinkle)
Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Clinical Research Unit
Brussels, , Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-001248-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0221099
Identifier Type: -
Identifier Source: org_study_id
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