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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cohort 1
Intervention: Fesoterodine ER (fasted) (Drug)
Cohort 1
Intervention: Fesoterodine SR3 (fasted) (Drug)
Cohort 1
Intervention: Fesoterodine SR3 (fed) (Drug)
Cohort 1
Intervention: Fesoterodine ER (fed) (Drug)
Cohort 1
Intervention: Fesoterodine SR3 (sprinkle) (Drug)
Cohort 2
Intervention: Fesoterodine ER (fasted) (Drug)
Cohort 2
Intervention: Fesoterodine SR4 (fasted) (Drug)
Cohort 2
Intervention: Fesoterodine SR4 (fed) (Drug)
Cohort 2
Intervention: Fesoterodine ER (fed) (Drug)
Cohort 2
Intervention: Fesoterodine SR4 (sprinkle) (Drug)
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 48 hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: 48 hours
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Secondary Outcomes
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(48 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(48 hours)
- Plasma Decay Half-Life (t1/2)(48 hours)