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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Treatment D; Drug: Treatment A; Drug: Treatment C; Drug: Treatment B; Drug: Treatment E

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043276

B0751001

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

Treatment A

Experimental group

Treatment:

Drug: Treatment A

Treatment B

Experimental group

Treatment:

Drug: Treatment B

Treatment C

Experimental group

Treatment:

Drug: Treatment C

Treatment D

Experimental group

Treatment:

Drug: Treatment D

Treatment E

Experimental group

Treatment:

Drug: Treatment E