Status:
COMPLETED
A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
Lead Sponsor:
Fontem Ventures BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
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 rela...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03822546
Start Date
April 1 2018
End Date
April 30 2018
Last Update
January 30 2019
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502