Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
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 impact of the study drug on Chinese healthy smokers' body) of varenicline.
Inclusion Criteria:

 -  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:

 -  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.