Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-30 @ 5:48 AM
Study NCT ID:
NCT03993795
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD190103: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
CSD190103: An Unblinded, Randomized, Multi-site, Two-way Crossover Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products A19010-W and B19010-F in Healthy Adult Snus Consumers.
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-W and B19010-F).
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-W and B19010-F 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-W and B: B19010-F) 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: