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.

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.

Inclusion Criteria:

• Healthy male subject aged 18 to 45 years (inclusive)
• Current smoker of < or = 10 cigarettes/day
• Fagerström score < or = 5
• Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion

Exclusion Criteria:

• Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
• Current or recurrent buccal lesions