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Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

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NCT00452894

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Beijing, , China
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00452894
Pfizer
Completed
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

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Pfizer Clinical Trials Contact Center

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[email protected]

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Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy 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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Smoking
Drug: varenicline tartrate
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00452894
A3051076
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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