Nicotine Patch Bioequivalence Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658202

Enrollment

Registered

2012-08-06

Start date

2012-08-31

Completion date

2012-09-30

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Smokers

Keywords

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

Brief 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.

Interventions

DRUGV0116 transdermal patch (Test treatment )

DRUGNicotine transdermal patch (Reference Treatment )

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic profile	Blood samples will be collected on Days 1, 3, 5 and 7	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

Measure	Time frame	Description
Clinical safety (reported adverse events)	up to day 9	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026