NCT01521767

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 17, 2012

Last Update Submit

January 26, 2021

Conditions

Urinary Bladder, Overactive

Keywords

pharmacokineticsrelative bioavailabilitytolterodine microspheres in powder blendOveractive Urinary Bladder

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine

    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

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

Secondary Outcomes (8)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.

    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

    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

    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

    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

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

  • +3 more secondary outcomes

Study Arms (5)

A

EXPERIMENTAL

4 mg tolterodine extended release capsules, administered with water and under fasting condition.

Drug: tolterodine tartrate

B

EXPERIMENTAL

4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.

Drug: tolterodine tartrate

C

EXPERIMENTAL

4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.

Drug: tolterodine tartrate

D

EXPERIMENTAL

4 mg MPB-RR1, administered without water and under fed condition.

Drug: tolterodine tartrate

E

EXPERIMENTAL

4 mg MPB-RR1, administered with water and under fasting condition.

Drug: tolterodine tartrate

Interventions

tolterodine tartrateDRUG

4 mg single dose of extended release capsules

A

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Evidence or history of clinically significant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 31, 2012

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

SG(1)