Nicotine Patch Bioequivalence Study

Pierre Fabre Medicament28 enrolled

Overview

The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation. 4 single 24hour applications separated by 48hour intervals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Smokers

Interventions

V0116 transdermal patch (Test treatment )DRUG

Nicotine transdermal patch (Reference Treatment )DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subject aged 18 to 45 years (inclusive) * Current Smoker of \>or = 5 and \< or = 15 cigarettes/day * Fagerström score \< or =5 at selection * Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram 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) 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 assessment of transdermal patch

Locations (1)

Unnamed facility

Rennes, France

Outcomes

Primary Outcomes

Pharmacokinetic profile

Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations

Time frame: Blood samples will be collected on Days 1, 3, 5 and 7

Secondary Outcomes

Clinical safety (reported adverse events)

General and local safety by evaluating the number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram, haematology and biochemistry

Time frame: up to day 9

Data from ClinicalTrials.gov

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