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Pharmacokinetics and Relative Bioavailability Study

Last updated on December 16, 2017

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 the ages of 21 and 55 years, 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 diseases

NCT01521767
Pfizer
Completed
Pharmacokinetics and Relative Bioavailability Study

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Pharmacokinetics and Relative Bioavailability Study
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
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
Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Urinary Bladder, Overactive
  • Drug: tolterodine tartrate
    4 mg single dose of extended release capsules
  • Drug: tolterodine tartrate
    4 mg single dose of microspheres in powder blend
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01521767
A6121196
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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