Study to Assess PK of 6 Oral Nicotine Products in Adult Smokers
Research type
Research Study
Full title
Single Exposure, Randomised, Crossover Study to Assess the Pharmacokinetics of Six Oral Nicotine Products in Adult Smokers Under Fasting Conditions
IRAS ID
362705
Contact name
Devinda Weeraratne
Contact email
Sponsor organisation
British American Tobacco (Investments) Limited
Duration of Study in the UK
0 years, 4 months, 18 days
Research summary
SINGLE EXPOSURE, RANDOMISED, CROSSOVER STUDY TO ASSESS THE PHARMACOKINETICS (Nicotine plasma concentrations will be measured) OF SIX ORAL NICOTINE PRODUCTS IN ADULT SMOKERS UNDER FASTING CONDITIONS.
This is a single centre, randomised, single-exposure, laboratory-blinded , 6-test sessions, 6 sequence, crossover study.
Duration of clinical study (per participant):Screening: Day -28 to Day -2 (up to 27 days)Eligible participants will be admitted to the clinical site on Day -2. Participants will be confined to the clinical site for at least 36 hours prior to product administration in Test Session 1 (Day 1) until after the last product administration in Test Session 6 and EOS procedures are complete (Day 6). Participants will be confined to the clinical site for approximately 8 days.
Wash-out period between product administrations: 24hrs minimum between the start of product administrations in Test Sessions 1, 2, 3, 4, 5 & 6.
Total study duration: up to 36 days (including Screening)Eligible participants will undergo a training session on how to correctly administer the different nicotine products on Day-2, prior to the first product administration. Following successful completion of the training session, participants will be randomised to receive 1 of 6 sequences. For each sequence, the product administrations will be separated by at least 24 hours (between the start of product administrations).PK blood samples will be collected up to 12 hours after the start of IP use for each test session.
Following products are involved: ZONNIC Nicotine Pouch 2mg, ZONNIC Mini Nicotine Pouch 4mg, ZONNIC Mini Nicotine Pouch 2mg, Nicorette® Lozenge Mint 2 mg nicotine resinate, ZONNIC® Nicotine Pouch 4mg Nicotine and Nicorette®Gum Extreme Chill®Mint 2 mg nicotine
In each test session, a product containing 2 mg or 4 mg of nicotine will be administered orally in the morning, following a minimum of an 8-hour overnight fast.
Study will be funded by British American Tobacco (Investments) Limited and Nicoventures Trading Limited.
REC name
Wales REC 2
REC reference
25/WA/0296
Date of REC Opinion
29 Oct 2025
REC opinion
Further Information Favourable Opinion