Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00452894
First received: March 26, 2007
Last updated: March 28, 2008
Last verified: March 2008
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Purpose
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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452894
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452894
Locations
| China | |
| Pfizer Investigational Site | |
| Beijing, China | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00452894 History of Changes |
| Other Study ID Numbers: | A3051076 |
| Study First Received: | March 26, 2007 |
| Last Updated: | March 28, 2008 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016