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Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
(110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI
upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for
inclusion.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at screening.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

NCT00864786
Pfizer
Completed
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

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