Nicotine Patch - Bioequivalence Study

Pierre Fabre

Status and phase: Completed; Phase 1

Conditions: Healthy Smokers

Treatments: Drug: Test treatment : V0116 transdermal patch; Drug: Reference treatment : Nicotine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089308

2013-005290-47 (EudraCT Number)

V00116 TD 1 06

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

74 participants in 2 patient groups

Treatment-Sequence 1

Other group

Description:

Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.

Treatment:

Drug: Reference treatment : Nicotine transdermal patch

Drug: Test treatment : V0116 transdermal patch

Treatment-Sequence 2

Other group

Description:

Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.

Treatment:

Drug: Reference treatment : Nicotine transdermal patch

Drug: Test treatment : V0116 transdermal patch