Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

Healthy Smokers Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574898
• Other study ID #: V00474 PC 1 01
• Secondary ID: 2012-000419-94
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2012
• Last updated: July 6, 2012
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Smokers

Intervention

Drug:
• V0474 - A mg
Single oral administration
• V0474 - B mg
Single oral administration
• V0474 - C mg
Single oral administration
• V0018 - B mg
Single oral administration
• Niquitin® Fresh Mint 4 mg
Single oral administration

Locations

Country	Name	City	State
France	Eurofins Optimed	Gieres

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers	Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers by measuring Maximum Plasma Concentration (Cmax), Time of Maximum Concentration (Tmax) , Area under the nicotine plasma concentration curve (AUC0-t), for each test and reference formulations	12 time points up to 6h after oral administration	No
Secondary	Clinical safety (reported adverse events)	Safety by evaluating the number of subjects with emergent adverse events and changes from baseline to end of study in vital signs, Electrocardiogram (ECG) and clinical laboratory parameters.	Screening up to Day 5	Yes
Secondary	Acceptability questionnaire	Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time	Up to complete lozenge dissolution, about 30 minutes (4 times)	No