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Relative Bioavailability Study

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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. 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 or 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 legal
representative, as applicable.

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

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 disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

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

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor within 6 months of Screening.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
medication.

- Screening supine blood pressure greater than or equal to140 mm Hg (systolic) or
greater than or equal to 90 mm Hg (diastolic), on a single measurement per local SOP.

- 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If
QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTc or QRS values should be used to determine the
subject's eligibility.

- 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 FSH test results at Screening.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of study medication. Herbal
supplements and hormone replacement therapy must be discontinued 28 days prior to the
first dose of study medication. As an exception, acetaminophen/paracetamol may be used
at doses of less than or equal to1 g/day. Limited use of non prescription medications
that are not believed to affect subject safety or the overall results of the study may
be permitted on a case-by-case basis following approval by the sponsor.

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

- Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

- Subjects who are investigational site staff members or relatives of those site staff
members or subjects who are Pfizer employees directly involved in the conduct of the
trial.

NCT01602887
Pfizer
Completed
Relative Bioavailability Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Pfizer Clinical Trials Contact Center

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