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OpenTrials
Completed

NCT Number: NCT00452894

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

varenicline tartrate

Drug

Primary outcomes

  1. The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.

Secondary outcomes

  1. To gather safety data from Day 0 to Day 17 of the study.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers

Important dates

Study start
2007
Study completion
2007
First posted
Mar 28, 2007
Registry last updated
Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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