Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy 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.