A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 2/1/2019 |
| Start Date: | April 1, 2018 |
| End Date: | April 30, 2018 |
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.
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
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