Status:
COMPLETED
Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Smoking
Eligibility:
All Genders
23-55 years
Phase:
NA
Brief Summary
The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the ...
Detailed Description
This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR for 5 days. 11...
Eligibility Criteria
Inclusion
- Caucasian adult smokers (male and female), with acceptable health conditions, aged from 23 to 55 years who usually smoke 10 to 30 non-mentholated conventional cigarettes (with a maximum ISO tar yield of 10 mg) per day, for at least the last 5 consecutive years, will be enrolled in this study.
Exclusion
- women of childbearing potential must be excluded if:Subject is pregnant (does not have negative pregnancy tests at screening and at D-2) or breastfeeding/ subject does not agree to use an acceptable method of effective contraception: intrauterine device, intrauterine system, established use of oral/injectable/implantable/ transdermal hormonal methods, barrier methods of contraception (condoms, occlusive caps) with spermicidal foam/gel/film/suppository, vasectomised partner or true abstinence (periodic abstinence and withdrawal are not effective methods) until the end of the safety follow-up period.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00812279
Start Date
November 1 2008
End Date
February 1 2009
Last Update
November 7 2019
Active Locations (1)
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1
MTZ Clinical Research Inc.
Warsaw, Poland, 02-106