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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043276

Enrollment

Registered

2010-01-06

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2010-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Healthy

Brief 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

Interventions

DRUGTreatment A

PF-00258210 220 µg using inhaler A

DRUGTreatment B

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

DRUGTreatment C

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

DRUGTreatment D

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

DRUGTreatment E

PF-00258210 220 µg using inhaler B

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
plasma pharmacokinetics AUClast and Cmax	Day 1

Secondary

Measure	Time frame
plasma pharmacokinetics, AUCinf and Tmax	Day 1

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026