Nicotine Patch Bioequivalence Study

Pierre Fabre

Status and phase: Completed; Phase 1

Conditions: Healthy Smokers

Treatments: Drug: Nicotine transdermal patch (Reference Treatment ); Drug: V0116 transdermal patch (Test treatment )

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658202

2011-006212-32 (EudraCT Number)

V00116 TD 1 04

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

Sequence 1

Other group

Description:

After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h.

Treatment:

Drug: Nicotine transdermal patch (Reference Treatment )

Drug: V0116 transdermal patch (Test treatment )

Sequence 2

Other group

Description:

After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h.

Treatment:

Drug: Nicotine transdermal patch (Reference Treatment )

Drug: V0116 transdermal patch (Test treatment )