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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NCT02160158

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 6, 2014)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02160158
Other Study ID Numbers  ICMJE A0221099
2014-001248-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP