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NCT01181700 Clinical Trial

A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

Pharmacokinetics Clinical Trial

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 NCT01181700
Other study ID # B0871015
Secondary ID
Status Completed
Phase Phase 1
First received August 11, 2010
Last updated January 21, 2011
Start date October 2010
Est. completion date January 2011

Study information
Verified date January 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Authority and EC
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 42
Est. completion date January 2011
Est. primary completion date January 2011
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 300 ug using inhaler A
• Treatment B
PF-00241939 300 ug using inhaler A
• Treatment C
PF-00241939 300 ug using inhaler A
• Treatment D
PF-00241939 300 ug using inhaler B
• Treatment E
PF-00241939 300 ug using inhaler B
• Treatment F
PF-00241939 300 ug using inhaler B
• Treatment G
PF-00241939 300 ug 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 and Cmax. 36 hours No
Secondary Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life. 36 hours No
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