Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

July 6, 2012 updated by: Pierre Fabre Medicament

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gieres, France
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 time points up to 6h after oral administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening up to Day 5
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
Up to complete lozenge dissolution, about 30 minutes (4 times)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (ESTIMATE)

April 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • V00474 PC 1 01
  • 2012-000419-94 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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