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Completed

NCT Number: NCT01043276

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment A

Drug

PF-00258210 220 µg using inhaler A

Treatment B

Drug

PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A

Treatment C

Drug

PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A

Treatment D

Drug

PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A

Treatment E

Drug

PF-00258210 220 µg using inhaler B

Primary outcomes

  1. plasma pharmacokinetics AUClast and Cmax

    Time frame: Day 1

Secondary outcomes

  1. plasma pharmacokinetics, AUCinf and Tmax

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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