Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
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ClinicalTrials.gov Identifier: NCT01574898 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : July 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Smokers | Drug: V0474 - A mg Drug: V0474 - B mg Drug: V0474 - C mg Drug: V0018 - B mg Drug: Niquitin® Fresh Mint 4 mg | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Niquitin® Fresh Mint 4 mg |
Drug: Niquitin® Fresh Mint 4 mg
Single oral administration |
Active Comparator: V0118 - B mg |
Drug: V0018 - B mg
Single oral administration |
Experimental: V0474 - C mg |
Drug: V0474 - C mg
Single oral administration |
Experimental: V0474 - B mg |
Drug: V0474 - B mg
Single oral administration |
Experimental: V0474 - A mg |
Drug: V0474 - A mg
Single oral administration |
- Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers [ Time Frame: 12 time points up to 6h after oral administration ]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
- Clinical safety (reported adverse events) [ Time Frame: Screening up to Day 5 ]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.
- Acceptability questionnaire [ Time Frame: Up to complete lozenge dissolution, about 30 minutes (4 times) ]Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574898
France | |
Eurofins Optimed | |
Gieres, France |
Responsible Party: | Pierre Fabre Medicament |
ClinicalTrials.gov Identifier: | NCT01574898 |
Other Study ID Numbers: |
V00474 PC 1 01 2012-000419-94 ( EudraCT Number ) |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | July 10, 2012 |
Last Verified: | July 2012 |
Smoking cessation Nicotine Tobacco Use Disorder Central Nervous System Agents |