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Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 26, 2007
Last updated: March 28, 2008
Last verified: March 2008
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.

Condition Intervention Phase
Smoking Drug: varenicline tartrate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.

Secondary Outcome Measures:
  • To gather safety data from Day 0 to Day 17 of the study.

Estimated Enrollment: 14
Study Start Date: March 2007
Study Completion Date: March 2007

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00452894

Pfizer Investigational Site
Beijing, China
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00452894     History of Changes
Other Study ID Numbers: A3051076
Study First Received: March 26, 2007
Last Updated: March 28, 2008

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 19, 2017