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Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
East Grand Forks, Minnesota, 58721 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
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 ECG and clinical laboratory tests.

- Currently smoking and have smoked an average of at least 10 cigarettes per day during
the past year, with no period of abstinence greater than 3 continuous 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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- 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 time of dosing).

- Pregnant or nursing women are excluded; women of childbearing potential (WOCBP) who
are unwilling or unable to use an acceptable method of contraception as outlined in
the protocol from at least 14 days prior to study medication administration until
completion of protocol-required procedures are excluded.

- Subjects with an estimated creatinine clearance (CLcr) method of Cockcroft and Gault.

NCT00527150
Pfizer
Completed
Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

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