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

> **NCT03398876** · PHASE1 · COMPLETED · sponsor: **Janssen Pharmaceutical K.K.** · enrollment: 24 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Oromucosal Nicotine Spray (ONS)
- **DRUG:** Nicotine Gum
- **OTHER:** Cigarette

## Key facts

- **NCT ID:** NCT03398876
- **Lead sponsor:** Janssen Pharmaceutical K.K.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-12-22
- **Primary completion:** 2018-04-16
- **Final completion:** 2018-04-16
- **Target enrollment:** 24 (ACTUAL)
- **Last updated:** 2025-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03398876

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03398876, "A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers". Retrieved via AI Analytics 2026-07-02 from https://api.ai-analytics.org/clinical/NCT03398876. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*