NCT03398876

A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oromucosal Nicotine Spray (ONS)	Participants will receive oral dose of oromucosal nicotine spray (ONS).
DRUG	Nicotine Gum	Participants will chew nicotine gum for 30 minutes.
OTHER	Cigarette	Participants will smoke one cigarette as 10 puffs for 3 minutes.

Timeline

• Start date: 2017-12-22
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2018-01-16
• Last updated: 2025-02-03

Locations

1 site across 1 country: Japan