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Food Effect Study Of AG-013736 In Healthy Volunteers

Last updated on March 15, 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.
Healthy Volunteers
Sex
Females and Males
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 and/or female 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 Electrocardiogram (ECG) and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- An informed consent document signed and dated by the subject or a legally acceptable
representative.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence of history of clinically significant blood, kidney, endocrine,
gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at time of
dosing) disease or clinical findings at Screening.

- Active smokers or users of other tobacco products as well as users of certain drugs.

- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who
are postmenopausal (defined as being amenorrheic for at least 2 years) must have
confirmatory Follicle-stimulating hormone (FSH) test results at Screening.

NCT00918632
Pfizer
Completed
Food Effect Study Of AG-013736 In Healthy Volunteers

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