NCT03993782

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	A19010-R	A snus product
OTHER	B19010-O	A snus product

Timeline

• Start date: 2019-07-08
• Primary completion: 2019-09-13
• Completion: 2019-09-13
• First posted: 2019-06-21
• Last updated: 2019-10-25

Locations

6 sites across 1 country: United States