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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Treatment A; Drug: Treatment B

• Registration Number: NCT00867282
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Study Start: 2009-06
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-27
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Treatment A	-
Treatment B	Treatment B	-

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic parameters: AUClast & Cmax.	48 hours

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.	48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore