Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers|
- The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
- To gather safety data from Day 0 to Day 17 of the study.
|Study Start Date:||March 2007|
|Study Completion Date:||March 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452894
|Pfizer Investigational Site|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|