NCT02688374

A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers

A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, single-dose, three-period, crossover, single-center comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult participants with a history of cigarette smoking. The participants will be admitted to the investigational clinic at least 38 hours before dosing and will remain domiciled until the completion of all study procedures at approximately 24 hours after dosing. Three toothpastes (one is commercial non-medicated non-nicotine containing chewing gum and other two are nicotine containing gums) will be provided across the 3 treatment periods. During each of the 3 treatment periods, participants will be under supervision in a non-smoking area and will abstain from smoking.There will be a total of at least 7 days and not more than 10 days (clinical furlough period) between treatment periods. Twenty (20) blood samples will be collected for pharmacokinetic (PK) analysis at baseline and multiple time points following study drug administration. The trial duration will be approximately 49 days and up to 55 days from screening to study end including the screening period.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	Treatment A: Nicorette 2 mg coated mint gum	Participants will be administered with 2 mg coated mint gum of Nicorette
OTHER	Treatment B: Nicotinell 2 mg coated mint gum	Participants will be administered with 2 mg coated mint gum of Nicotinell
OTHER	Treatment C: Nicotinell 2 mg coated fruit flavor gum	Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell

Timeline

• Start date: 2016-03-11
• Primary completion: 2016-06-12
• Completion: 2016-06-12
• First posted: 2016-02-23
• Last updated: 2017-12-19

Locations

1 site across 1 country: China