Nicotine Patch Bioequivalence Study

Phase 1

Completed

• Conditions: Healthy Smokers
• Interventions: Drug: V0116 transdermal patch (Test treatment ); Drug: Nicotine transdermal patch (Reference Treatment )

• Registration Number: NCT01658202
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-31
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	V0116 transdermal patch (Test treatment )	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.
Sequence 1	Nicotine transdermal patch (Reference Treatment )	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.
Sequence 2	V0116 transdermal patch (Test treatment )	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.
Sequence 2	Nicotine transdermal patch (Reference Treatment )	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile	Blood samples will be collected on Days 1, 3, 5 and 7	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

Secondary Outcome Measures

Name	Time	Method
Clinical safety (reported adverse events)	up to day 9	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