Nicotine Patch - Bioequivalence Study

NCT02089308 | Completed Phase 1

• 2 other identifiers: V00116 TD 1 062013-005290-47
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Smokers

Keywords

Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  During the third application of each period,12 time points up to 24h after the application

• Time to Maximum Concentration (Tmax)

  During the third application of each period,12 time points up to 24h after the application

• Area under the plasma concentration-time curve (AUC)

  During the third application of each period, 12 time points up to 24h after the application

Study Arms (2)

Treatment-Sequence 1

OTHER

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

OTHER

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

Interventions

Test treatment : V0116 transdermal patch DRUG

Treatment-Sequence 1; Treatment-Sequence 2

Reference treatment : Nicotine transdermal patch DRUG

Treatment-Sequence 1; Treatment-Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Unknown Facility

Gières, 38610, France

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

FR (1)