Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Smoking

Treatments

Drug: varenicline tartrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452894

A3051076

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.