Pharmacokinetics and Relative Bioavailability Study

NCT ID: NCT01521767

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

tolterodine tartrate

Intervention Type DRUG

4 mg single dose of extended release capsules

B

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

Group Type EXPERIMENTAL

tolterodine tartrate

Intervention Type DRUG

4 mg single dose of microspheres in powder blend

C

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

Group Type EXPERIMENTAL

tolterodine tartrate

Intervention Type DRUG

4 mg single dose of microspheres in powder blend

D

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

Group Type EXPERIMENTAL

tolterodine tartrate

Intervention Type DRUG

4 mg single dose of microspheres in powder blend

E

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

Group Type EXPERIMENTAL

tolterodine tartrate

Intervention Type DRUG

4 mg single dose of microspheres in powder blend

Interventions

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tolterodine tartrate

4 mg single dose of extended release capsules

Intervention Type DRUG

tolterodine tartrate

4 mg single dose of microspheres in powder blend

Intervention Type DRUG

tolterodine tartrate

4 mg single dose of microspheres in powder blend

Intervention Type DRUG

tolterodine tartrate

4 mg single dose of microspheres in powder blend

Intervention Type DRUG

tolterodine tartrate

4 mg single dose of microspheres in powder blend

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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Other Identifiers

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A6121196

Identifier Type: -

Identifier Source: org_study_id

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