Nicotine Patch Bioequivalence Study

NCT01658202 | Completed Phase 1

• 2 other identifiers: V00116 TD 1 042011-006212-32
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Smokers

Keywords

Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• Clinical safety (reported adverse events)

  up to day 9

Study Arms (2)

Sequence 1

OTHER

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.

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

Sequence 2

OTHER

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.

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

Interventions

V0116 transdermal patch (Test treatment ) DRUG

Sequence 1; Sequence 2

Nicotine transdermal patch (Reference Treatment ) DRUG

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Unknown Facility

Rennes, France

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 6, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

FR (1)