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Nicotine Patch - Bioequivalence Study

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ClinicalTrials.gov Identifier: NCT02089308
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Smokers Drug: Test treatment : V0116 transdermal patch Drug: Reference treatment : Nicotine transdermal patch Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment-Sequence 1

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.

Drug: Test treatment : V0116 transdermal patch
Drug: Reference treatment : Nicotine transdermal patch
Treatment-Sequence 2

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.

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



Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: During the third application of each period,12 time points up to 24h after the application ]
  2. Time to Maximum Concentration (Tmax) [ Time Frame: During the third application of each period,12 time points up to 24h after the application ]
  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: During the third application of each period, 12 time points up to 24h after the application ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089308


Locations
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France
Gieres, France, 38610
Sponsors and Collaborators
Pierre Fabre Medicament

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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02089308     History of Changes
Other Study ID Numbers: V00116 TD 1 06
2013-005290-47 ( EudraCT Number )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Keywords provided by Pierre Fabre Medicament:
Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action