Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 impact of the study drug on Chinese healthy smokers' body) of varenicline.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Varenicline

Criteria

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.