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Pharmacokinetics and Relative Bioavailability Study

Last updated on November 9, 2019

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant diseases

NCT01521767
Pfizer
Completed
Pharmacokinetics and Relative Bioavailability Study

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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 SummaryA 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 DescriptionPharmacokinetics 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 DateNovember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2012

ICMJE     Data element required by the

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

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