Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Phase 1
Completed
- Conditions
- Smoking
- Registration Number
- NCT00452894
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
- Secondary Outcome Measures
Name Time Method To gather safety data from Day 0 to Day 17 of the study.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Beijing, China