Nicotine Patch Bioequivalence Study
This study has been completed.
Sponsor:
Pierre Fabre Medicament
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
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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 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: L’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:
|
Central Nervous System Agents Nicotine polacrilex Nicotine Therapeutic Uses Pharmacologic Actions 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 Central Nervous System Stimulants |
ClinicalTrials.gov processed this record on May 16, 2013