A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

NCT ID: NCT00928278

Last Updated: 2009-12-21

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A - PF-04764793

PF-04764793 using inhaler A

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Inhaled, 300/150, single dose

Treatment B - PF-04764793

PF-04764793 using inhaler B

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Inhaled, 300/150, single dose

Treatment C - PF-04764793

PF-04764793 using inhaler A

Group Type EXPERIMENTAL

Treatment C

Intervention Type DRUG

Inhaled, 300/150, single dose + oral activated charcoal block

Treatment D - PF-04764793

PF-04764793 using inhaler B

Group Type ACTIVE_COMPARATOR

Treatment D

Intervention Type DRUG

Inhaled, 300/150, single dose + oral activated charcoal block

Interventions

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Treatment A

Inhaled, 300/150, single dose

Intervention Type DRUG

Treatment B

Inhaled, 300/150, single dose

Intervention Type DRUG

Treatment C

Inhaled, 300/150, single dose + oral activated charcoal block

Intervention Type DRUG

Treatment D

Inhaled, 300/150, single dose + oral activated charcoal block

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.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

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

Other Identifiers

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B1691001

Identifier Type: -

Identifier Source: org_study_id

NCT00977535

Identifier Type: -

Identifier Source: nct_alias