title: A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part A: Pharmacokinetics.
abstract: The pharmacokinetic (PK) profile of nicotine delivered by an Electronic Vapour Product (EVP) was characterised in a 2-part study in smokers. The study was designed as a randomised, controlled, four-way crossover trial. Part 1 compared an unflavoured e-liquid (UF2.0%) and a flavoured e-liquid (FL2.0%) to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette(®); 15 mg). Part 2 compared e-liquids with increasing nicotine concentrations (0%, 0.4%, 0.9%, 2.0%). Subjects used each different product for a daily use session. In Part 1, maximum plasma nicotine concentration (Cmax) for UF2.0%, FL2.0%, Nicorette(®) and CC was 3.6, 2.5, 2.5 and 21.2 ng/mL, respectively. The time to maximum plasma nicotine concentration (Tmax) was longer for the EVP (UF2.0%, 9.0 min; FL2.0%, 10.0 min) and the nicotine inhalator (13.0 min) compared to CC (3.0 min). In Part 2, EVP with 0%, 0.4%, 0.9% and 2.0% nicotine produced Cmax values of 0.6, 1.0, 1.9 and 3.6 ng/mL, respectively. At the maximum nicotine concentration of 2% as prescribed by the European Tobacco Directive, the EVP achieved nicotine delivery that was comparable to the inhalator. EVPs thus offer a potential alternative to nicotine inhalator devices for those finding it difficult to quit smoking.
authors.affiliation: Fontem Ventures, Barbara Strozzilaan 101, 1083 HN Amsterdam, Netherlands. Electronic address: tanvir.walele@fontemventures.com.
authors.forename: Tanvir
authors.initials: T
authors.lastname: Walele
authors.affiliation: Simbec Research, Merthyr Tydfil CF48 4DR, UK.
authors.forename: Girish
authors.initials: G
authors.lastname: Sharma
authors.affiliation: Clinopsis S.A., Jardins 6, 1426 Concise, Switzerland.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Savioz
authors.affiliation: Clinopsis S.A., Jardins 6, 1426 Concise, Switzerland.
authors.forename: Claire
authors.initials: C
authors.lastname: Martin
authors.affiliation: Imperial Tobacco, Product Science, 121 Winterstoke Road, Bristol, UK.
authors.forename: Josie
authors.initials: J
authors.lastname: Williams
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D018592:Cross-Over Studies; D066300:Electronic Nicotine Delivery Systems; D006207:Half-Life; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009538:Nicotine / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D012907:Smoking / Q000097:blood; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D014029:Tobacco Use Disorder / Q000097:blood / Q000517:prevention & control*; D014835:Volatilization; D014852:Wales; D055815:Young Adult
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine
keywords: Cigarette; Clinical study; Electronic cigarette; Electronic vapour product; Nicotine; Nicotine inhalator; Pharmacokinetics