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Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574898
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Study Description
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Brief 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.

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 Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Eurofins Optimed
Gieres, France
Sponsors and Collaborators
Pierre Fabre Medicament
More Information
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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
Keywords provided by Pierre Fabre Medicament:
Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents