A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations

A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers

This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.

Inclusion Criteria:

• Having smoked ≥10 manufactured cigarettes per day for at least the last year
• Expired carbon monoxide level of >10 ppm at screening
• Tested positive for urinary cotinine (≥500 ng/mL)

Exclusion Criteria:

• Known or suspected hypersensitivity to any component of the e-liquid formulations
• Taking or receiving prescription smoking cessation medicines
• Willing or considering to stop smoking
• Smokers who draw smoke into their mouth and throat but do not inhale
• Relevant illness history
• Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
• Breastfeeding women
• Women of child-bearing potential who were not using an accepted method of contraception