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NCT03822546

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

Completed NA Last updated 30 January 2019
What this trial tests

NA trial testing Conventional cigarette in Healthy Volunteers in 15 participants. Completed in 30 April 2018.

Timeline
1 April 2018
Primary endpoint
30 April 2018
30 April 2018

Quick facts

Lead sponsorFontem Ventures BV
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment15
Start date1 April 2018
Primary completion30 April 2018
Estimated completion30 April 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Fontem Ventures BV

Who can join

Adults 25 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers.
    O'Connell G, Pritchard JD, Prue C, Thompson J, et al · · 2019 · cited 77× · PMID 30712148 · DOI 10.1007/s11739-019-02025-3

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Other trials of Conventional cigarette

Trials testing the same drug.

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other Fontem Ventures BV trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03822546.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing