Nicotine Patch - Bioequivalence Study

The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications

Completed

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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

Gières, 38610, 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 = 5 and < or = to 15 cigarettes/day
Fagerström score < or =5 at selection
Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion criteria

Presence of any significant medical findings or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) 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
Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or safety assessment of a transdermal patch

Treatment and study plan

Test treatment : V0116 transdermal patch

Drug

Reference treatment : Nicotine transdermal patch

Drug

Primary outcomes

Maximum Plasma Concentration (Cmax)

Time frame: During the third application of each period,12 time points up to 24h after the application
Time to Maximum Concentration (Tmax)

Time frame: During the third application of each period,12 time points up to 24h after the application
Area under the plasma concentration-time curve (AUC)

Time frame: During the third application of each period, 12 time points up to 24h after the application

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 17, 2014
Registry last updated: Jun 12, 2014

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.

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

Completed