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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160158
• Other study ID #: A0221099
• Secondary ID: 2014-001248-39
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2014
• Last updated: January 14, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum Observed Plasma Concentration (Cmax)		48 hours	No
Secondary	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	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		48 hours	No
Secondary	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	No

External Links

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