A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
NCT ID: NCT03822546
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2018-04-01
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Conventional cigarette
The subject's preferred brand of commercially available conventional cigarette
Conventional cigarette
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
myblu 25 mg freebase
myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour
myblu 25 mg freebase
E-cigarette used for 10 inhalations every 30 seconds
myblu 16 mg nicotine salt
myblu pod-system containing 16 mg nicotine salt tobacco flavour
myblu 16 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
myblu 25 mg nicotine salt
myblu pod-system containing 25 mg nicotine salt tobacco flavour
myblu 25 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
myblu 40 mg nicotine salt
myblu pod-system containing 40 mg nicotine salt tobacco flavour
myblu 40 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
blu PRO 48 mg nicotine salt
blu PRO open-system containing 48 mg nicotine salt tobacco flavour
blu PRO 48 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
Interventions
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Conventional cigarette
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
myblu 25 mg freebase
E-cigarette used for 10 inhalations every 30 seconds
myblu 16 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
myblu 25 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
myblu 40 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
blu PRO 48 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
Eligibility Criteria
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Inclusion Criteria
* Expired carbon monoxide level of \>10 ppm at screening
* Tested positive for urinary cotinine (≥500 ng/mL)
Exclusion Criteria
* 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
25 Years
65 Years
ALL
Yes
Sponsors
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Fontem Ventures BV
INDUSTRY
Responsible Party
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Locations
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Celerion
Lincoln, Nebraska, United States
Countries
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Other Identifiers
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FON-01blu-2018
Identifier Type: -
Identifier Source: org_study_id
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