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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 December 5, 2018

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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A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Urinary Bladder, Overactive
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.).
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01566760
A0221069
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

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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