Nicotine Patch Bioequivalence Study

Healthy Smokers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658202
• Other study ID #: V00116 TD 1 04
• Secondary ID: 2011-006212-32
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2012
• Last updated: December 10, 2012
• Start date: August 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité de Protection des Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy Smokers

Intervention

Drug:
• V0116 transdermal patch (Test treatment )

• Nicotine transdermal patch (Reference Treatment )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical safety (reported adverse events)	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	up to day 9	Yes