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A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

Last updated on January 19, 2020

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 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 21 and 55 years of age(inclusive).

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

- Evidence or history of clinically significant disease.

- Evidence or history of urologic disease (benign prostate hyperplasia, recurrent
urinary tract infections, urinary retention, etc.).

NCT01566760
Pfizer
Completed
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Official Title  ICMJE Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers
Brief Summary This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.
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 Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
  • Drug: fesoterodine fumarate
    one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
Study Arms  ICMJE
  • Experimental: Treatment A, Cohort 1
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment B, Cohort 2
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment C, Cohort 1
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment D, Cohort 2
    Intervention: Drug: fesoterodine fumarate
  • Active Comparator: Treatment E, Cohort 1 and/or Cohort 2
    Intervention: Drug: fesoterodine fumarate
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
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between 21 and 55 years of age(inclusive).

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566760
Other Study ID Numbers  ICMJE A0221069
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 Center Pfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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