Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

Pierre Fabre

Status and phase: Completed; Phase 1

Conditions: Healthy Smokers

Treatments: Drug: V0018 - B mg; Drug: V0474 - B mg; Drug: Niquitin® Fresh Mint 4 mg; Drug: V0474 - A mg; Drug: V0474 - C mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574898

2012-000419-94 (EudraCT Number)

V00474 PC 1 01

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 5 patient groups

Niquitin® Fresh Mint 4 mg

Active Comparator group

Treatment:

Drug: Niquitin® Fresh Mint 4 mg

V0118 - B mg

Active Comparator group

Treatment:

Drug: V0018 - B mg

V0474 - C mg

Experimental group

Treatment:

Drug: V0474 - C mg

V0474 - B mg

Experimental group

Treatment:

Drug: V0474 - B mg

V0474 - A mg

Experimental group

Treatment:

Drug: V0474 - A mg