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Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

NCT ID: NCT01574898

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Smokers

Keywords

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Smoking cessation Nicotine Tobacco Use Disorder Central Nervous System Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Niquitin® Fresh Mint 4 mg

Group Type ACTIVE_COMPARATOR

Niquitin® Fresh Mint 4 mg

Intervention Type DRUG

Single oral administration

V0118 - B mg

Group Type ACTIVE_COMPARATOR

V0018 - B mg

Intervention Type DRUG

Single oral administration

V0474 - C mg

Group Type EXPERIMENTAL

V0474 - C mg

Intervention Type DRUG

Single oral administration

V0474 - B mg

Group Type EXPERIMENTAL

V0474 - B mg

Intervention Type DRUG

Single oral administration

V0474 - A mg

Group Type EXPERIMENTAL

V0474 - A mg

Intervention Type DRUG

Single oral administration

Interventions

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V0474 - A mg

Single oral administration

Intervention Type DRUG

V0474 - B mg

Single oral administration

Intervention Type DRUG

V0474 - C mg

Single oral administration

Intervention Type DRUG

V0018 - B mg

Single oral administration

Intervention Type DRUG

Niquitin® Fresh Mint 4 mg

Single oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurofins Optimed

Gières, , France

Site Status

Countries

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France

Other Identifiers

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2012-000419-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V00474 PC 1 01

Identifier Type: -

Identifier Source: org_study_id