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NCT00867282 Clinical Trial

A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers

Pharmacokinetics Clinical Trial

— B0871003  

Official title:
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00867282
Other study ID # B0871003
Secondary ID
Status Completed
Phase Phase 1
First received March 20, 2009
Last updated July 27, 2009
Start date June 2009
Est. completion date July 2009

Study information
Verified date July 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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/m2; 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).

- Pregnant or nursing females.

- A positive urine drug screen.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment A
PF-00241939 750ug using inhaler A
• Treatment B
PF-00241939 750ug using inhaler B

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma pharmacokinetic parameters: AUClast & Cmax. 48 hours No
Secondary Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½. 48 hours No
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