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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01566760
First received: March 27, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes

March 27, 2012
July 24, 2012
May 2012
July 2012   (final data collection date for primary outcome measure)
  • Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01566760 on ClinicalTrials.gov Archive Site
  • Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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.).
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01566760
A0221069
No
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