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Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Beijing, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking
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.
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- Healthy male and/or female Chinese subjects between the ages of 18 and 45 years,
inclusive.

- Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.

- Individuals who have smoked an average of at least 10 cigarettes per day during the
past year, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Heart rate>100 bpm, QRS Interval>120 msec, QTc Interval >430 msec, PR Interval>220
msec, or any other abnormalities observed on the Electrocardiogram.

- Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.

- Subjects with evidence or history of clinically significant allergic, hematological,
renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or
neurological disease, or any condition possibly affecting drug absorption.

NCT00452894
Pfizer
Completed
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

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Pfizer Clinical Trials Contact Center

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[email protected]

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