Status:
COMPLETED
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Lead Sponsor:
Pfizer
Conditions:
Smoking
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the imp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00452894
Start Date
March 1 2007
End Date
March 1 2007
Last Update
April 1 2008
Active Locations (1)
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1
Pfizer Investigational Site
Beijing, China