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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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02160158
Pfizer
Completed
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

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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
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
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Fesoterodine ER (fasted)
    Commercial Fesoterodine ER 4 mg (single dose)
  • Drug: Fesoterodine SR3 (fasted)
    Fesoterodine SR3 4 mg (single dose)
  • Drug: Fesoterodine SR3 (fed)
    Fesoterodine SR3 4 mg (single dose) with high-fat meal
  • Drug: Fesoterodine ER (fed)
    Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
  • Drug: Fesoterodine SR3 (sprinkle)
    Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
  • Drug: Fesoterodine SR4 (fasted)
    Fesoterodine SR4 4 mg (single dose)
  • Drug: Fesoterodine SR4 (fed)
    Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
  • Drug: Fesoterodine SR4 (sprinkle)
    Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
  • Experimental: Cohort 1
    Interventions:
    • Drug: Fesoterodine ER (fasted)
    • Drug: Fesoterodine SR3 (fasted)
    • Drug: Fesoterodine SR3 (fed)
    • Drug: Fesoterodine ER (fed)
    • Drug: Fesoterodine SR3 (sprinkle)
  • Experimental: Cohort 2
    Interventions:
    • Drug: Fesoterodine ER (fasted)
    • Drug: Fesoterodine SR4 (fasted)
    • Drug: Fesoterodine SR4 (fed)
    • Drug: Fesoterodine ER (fed)
    • Drug: Fesoterodine SR4 (sprinkle)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02160158
A0221099
2014-001248-39 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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