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Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

NCT01574898 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-07-10

No results posted yet for this study

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.

Conditions

  • Healthy Smokers

Interventions

DRUG

V0474 - A mg

Single oral administration

DRUG

V0474 - B mg

Single oral administration

DRUG

V0474 - C mg

Single oral administration

DRUG

V0018 - B mg

Single oral administration

DRUG

Niquitin® Fresh Mint 4 mg

Single oral administration

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574898 on ClinicalTrials.gov