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

NCT03822546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-01-30

No results posted yet for this study

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 relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Conventional cigarette

Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals

OTHER

myblu 25 mg freebase

E-cigarette used for 10 inhalations every 30 seconds

OTHER

myblu 16 mg nicotine salt

E-cigarette used for 10 inhalations every 30 seconds

OTHER

myblu 25 mg nicotine salt

E-cigarette used for 10 inhalations every 30 seconds

OTHER

myblu 40 mg nicotine salt

E-cigarette used for 10 inhalations every 30 seconds

OTHER

blu PRO 48 mg nicotine salt

E-cigarette used for 10 inhalations every 30 seconds

Sponsors & Collaborators

  • Fontem Ventures BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822546 on ClinicalTrials.gov