NCT01574898

Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.

Conditions

• Healthy Smokers

Interventions

Type	Name	Description
DRUG	V0474 - A mg	Single oral administration
DRUG	V0474 - B mg	Single oral administration
DRUG	V0474 - C mg	Single oral administration
DRUG	V0018 - B mg	Single oral administration
DRUG	Niquitin® Fresh Mint 4 mg	Single oral administration

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-04-10
• Last updated: 2012-07-10

Locations

1 site across 1 country: France