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CSD190102: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products

Tobacco Use Clinical Trial

Official title:
CSD190102: An Unblinded, Randomized, Multi-site, Two-way Crossover Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products A19010-R and B19010-O in Healthy Adult Snus Consumers.

Clinical Trial Summary

The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-R and B19010-O).

Clinical Trial Description

This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine pharmacokinetic parameters after use of two smokeless tobacco products A19010-R and B19010-O in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days and randomized to one of two investigational product (IP) (A: A19010-R and B: B19010-O) use sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, and then subjects will use the other product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03993782
Study type Interventional
Source RAI Services Company
Contact
Status Completed
Phase N/A
Start date July 8, 2019
Completion date September 13, 2019
View Details
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