clinical trial · NCT03398876
A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers
Janssen Pharmaceutical K.K.·phase1·completed·n = 24
HealthyOromucosal Nicotine Spray (ONS)Nicotine GumCigarette
brief summary
In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.
started
Dec 22, 2017
primary completion
Apr 16, 2018
completion
Apr 16, 2018
last updated
Feb 3, 2025
official title
A Single-dose and Repeated-dose, Open-label, Randomized, Cross-over Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With A New Oral Nicotine Replacement Product in Healthy Japanese Smokers.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol