Overview

Nicotine Patch - Multidose Bioequivalence Study

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation. Up to day 7
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pierre Fabre Medicament
Treatments:
Nicotine
Criteria
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