Back to resultsPharmacokinetics and Relative Bioavailability Study
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
tolterodine tartrate
tolterodine tartrate
tolterodine tartrate
tolterodine tartrate
tolterodine tartrate
Sponsored by
About this trial
This is an interventional other trial for Urinary Bladder, Overactive focused on measuring pharmacokinetics, relative bioavailability, tolterodine microspheres in powder blend, Overactive Urinary Bladder
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
E
Arm Description
4 mg tolterodine extended release capsules, administered with water and under fasting condition.
4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
4 mg MPB-RR1, administered without water and under fed condition.
4 mg MPB-RR1, administered with water and under fasting condition.
Outcomes
Primary Outcome Measures
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine
Maximum Observed Plasma Concentration (Cmax) of tolterodine
Secondary Outcome Measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT
Maximum Observed Plasma Concentration (Cmax) of 5-HMT
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT
Plasma Decay Half-Life (t1/2) of tolterodine
Plasma Decay Half-Life (t1/2) of 5-HMT
Full Information
NCT ID
NCT01521767
First Posted
January 17, 2012
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01521767
Brief Title
Pharmacokinetics and Relative Bioavailability Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
pharmacokinetics, relative bioavailability, tolterodine microspheres in powder blend, Overactive Urinary Bladder
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
4 mg tolterodine extended release capsules, administered with water and under fasting condition.
Arm Title
B
Arm Type
Experimental
Arm Description
4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
Arm Title
C
Arm Type
Experimental
Arm Description
4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
Arm Title
D
Arm Type
Experimental
Arm Description
4 mg MPB-RR1, administered without water and under fed condition.
Arm Title
E
Arm Type
Experimental
Arm Description
4 mg MPB-RR1, administered with water and under fasting condition.
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg single dose of extended release capsules
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg single dose of microspheres in powder blend
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg single dose of microspheres in powder blend
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg single dose of microspheres in powder blend
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
4 mg single dose of microspheres in powder blend
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121196&StudyName=Pharmacokinetics%20and%20Relative%20Bioavailability%20Study%20
Description
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Pharmacokinetics and Relative Bioavailability Study
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