Skip to main content
OpenTrials
Completed

NCT Number: NCT01574898

Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Smokers Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Eurofins Optimed

Gières, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0474 - A mg

Drug

Single oral administration

V0474 - B mg

Drug

Single oral administration

V0474 - C mg

Drug

Single oral administration

V0018 - B mg

Drug

Single oral administration

Niquitin® Fresh Mint 4 mg

Drug

Single oral administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.