Pharmacokinetics and Relative Bioavailability Study

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
4 mg tolterodine extended release capsules, administered with water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: B
4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: C
4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: D
4 mg MPB-RR1, administered without water and under fed condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: E
4 mg MPB-RR1, administered with water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6121196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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