Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
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ClinicalTrials.gov Identifier: NCT00452894 |
Recruitment Status
:
Completed
First Posted
: March 28, 2007
Last Update Posted
: April 1, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Drug: varenicline tartrate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 14 participants |
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 |
Study Start Date : | March 2007 |
Actual Study Completion Date : | March 2007 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452894
China | |
Pfizer Investigational Site | |
Beijing, China |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00452894 History of Changes |
Other Study ID Numbers: |
A3051076 |
First Posted: | March 28, 2007 Key Record Dates |
Last Update Posted: | April 1, 2008 |
Last Verified: | March 2008 |
Additional relevant MeSH terms:
Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |