A Phase 1 interventional study of V0474 - A mg and V0474 - B mg in Healthy Smokers, sponsored by Pierre Fabre Medicament. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by Pierre Fabre Medicament · Phase 1, Interventional, and Treatment
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.
Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Niquitin® Fresh Mint 4 mg
Drug: V0018 - B mg
Drug: V0474 - C mg
Drug: V0474 - B mg
Drug: V0474 - A mg
Single oral administration
Single oral administration
Single oral administration
Single oral administration
Single oral administration
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
Time frame: 12 time points up to 6h after oral administration
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.
Time frame: Screening up to Day 5
Acceptability questionnaire
Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time
Time frame: Up to complete lozenge dissolution, about 30 minutes (4 times)
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pierre Fabre Medicament