Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

NCT01887847

Nicotine Pharmacokinetic Study

COMPLETED PHASE1

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

NCT01234896

Tobacco Dependence

COMPLETED NA

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

NCT01084603

Tobacco Dependence

COMPLETED NA

Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

NCT01234792

Tobacco Dependence

COMPLETED NA

Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

NCT01227720

Tobacco Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Smokers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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