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Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy males and/or females of non-childbearing potential between the ages of 18 (or
21 based on country-specific age of consent) and 60 years, inclusive, at Screening.
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/safety laboratory tests.

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg,
pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5
half-lives (whichever is longer) prior to Day 1.

- Known history of hypersensitivity, allergy, severe adverse drug reaction or
intolerance to simvastatin or other statins.

NCT01445860
Pfizer
Completed
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

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[email protected]

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