Nicotine Patch Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01658202
First received: July 31, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Healthy Smokers
Drug: V0116 transdermal patch (Test treatment )
Drug: Nicotine transdermal patch (Reference Treatment )
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: Blood samples will be collected on Days 1, 3, 5 and 7 ] [ Designated as safety issue: No ]
    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:
  • Clinical safety (reported adverse events) [ Time Frame: up to day 9 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 28
Study Start Date: August 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence 1

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

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 )

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658202

Locations
France
Rennes, France
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01658202     History of Changes
Other Study ID Numbers: V00116 TD 1 04, 2011-006212-32
Study First Received: July 31, 2012
Last Updated: December 10, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Comité de Protection des Personnes

Keywords provided by Pierre Fabre Medicament:
Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014