Smoking
Conditions
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 impact of the study drug on Chinese healthy smokers' body) of varenicline.
Interventions
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To gather safety data from Day 0 to Day 17 of the study. | — |
Countries
China
Outcome results
None listed