Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

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NCT00452894

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Study Location
Pfizer Investigational Site
Beijing, , , China
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Official Title  ICMJE A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE Drug: varenicline tartrate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 27, 2007)		14
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452894
Other Study ID Numbers  ICMJE A3051076
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP