Nicotine Patch - Bioequivalence Study

Healthy Smokers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089308
• Other study ID #: V00116 TD 1 06
• Secondary ID: 2013-005290-47
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2014
• Last updated: June 11, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• 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: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Smokers

Intervention

Drug:
• Test treatment : V0116 transdermal patch

• Reference treatment : Nicotine transdermal patch

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	Maximum Plasma Concentration (Cmax)		During the third application of each period,12 time points up to 24h after the application	No
Primary	Time to Maximum Concentration (Tmax)		During the third application of each period,12 time points up to 24h after the application	No
Primary	Area under the plasma concentration-time curve (AUC)		During the third application of each period, 12 time points up to 24h after the application	No