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NCT01043276 Clinical Trial

A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

Asthma Clinical Trial

Official title:
A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01043276
Other study ID # B0751001
Secondary ID
Status Completed
Phase Phase 1
First received December 7, 2009
Last updated April 26, 2010
Start date January 2010
Est. completion date April 2010

Study information
Verified date April 2010
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 if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

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)

- A positive urine drug screen

- Pregnant or nursing females

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment A
PF-00258210 220 µg using inhaler A
• Treatment B
PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A
• Treatment C
PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A
• Treatment D
PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A
• Treatment E
PF-00258210 220 µg 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 pharmacokinetics AUClast and Cmax Day 1 No
Secondary plasma pharmacokinetics, AUCinf and Tmax Day 1 No
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