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Trial record 62 of 732 for:    Area Under Curve AND Bioavailability

Pharmacokinetics and Relative Bioavailability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521767
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 31, 2012
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of tolterodine [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine. [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of 5-HMT [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Plasma Decay Half-Life (t1/2) of tolterodine [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
  • Plasma Decay Half-Life (t1/2) of 5-HMT [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Relative Bioavailability Study
Official Title  ICMJE A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Brief Summary A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Detailed Description Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: tolterodine tartrate
    4 mg single dose of extended release capsules
  • Drug: tolterodine tartrate
    4 mg single dose of microspheres in powder blend
Study Arms  ICMJE
  • Experimental: A
    4 mg tolterodine extended release capsules, administered with water and under fasting condition.
    Intervention: Drug: tolterodine tartrate
  • Experimental: B
    4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
    Intervention: Drug: tolterodine tartrate
  • Experimental: C
    4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
    Intervention: Drug: tolterodine tartrate
  • Experimental: D
    4 mg MPB-RR1, administered without water and under fed condition.
    Intervention: Drug: tolterodine tartrate
  • Experimental: E
    4 mg MPB-RR1, administered with water and under fasting condition.
    Intervention: Drug: tolterodine tartrate
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: January 26, 2012)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant diseases
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 NCT01521767
Other Study ID Numbers  ICMJE A6121196
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 January 2012

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