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NCT00452894 Clinical Trial

Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452894
Other study ID # A3051076
Secondary ID
Status Completed
Phase Phase 1
First received March 26, 2007
Last updated March 28, 2008
Start date March 2007
Est. completion date March 2007

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline tartrate

Locations
Country Name City State
China Pfizer Investigational Site Beijing

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
Secondary To gather safety data from Day 0 to Day 17 of the study.
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