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Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Peking Union Medical College Hospital
Beijing, , 100032 China
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
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy Chinese volunteers (individuals currently residing in mainland China, who were
born in China, and whose parents are both of Chinese descent).

- Healthy male and/or female (of non-childbearing potential) subjects between the ages
of 18 and 45 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 or clinical
laboratory tests).

- Body Mass Index (BMI) of 19.0 to 24.0 kg/m2; and a total body weight should be 50 kg
(110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant dermatologic, 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).

- Drug dependency, a positive urine drug screen and/or alcohol dependency.

- Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men (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 or biologic within the last 3 months (or as
determined by the local requirement) or 5 half-lives preceding the first dose of study
medication, whichever is longer.

NCT02097433
Pfizer
Completed
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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