ClinicalTrials.Veeva

Menu

Nicotine Patch - Bioequivalence Study

Pierre Fabre logo

Pierre Fabre

Status and phase

Completed
Phase 1

Conditions

Healthy Smokers

Treatments

Drug: Test treatment : V0116 transdermal patch
Drug: Reference treatment : Nicotine transdermal patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02089308
2013-005290-47 (EudraCT Number)
V00116 TD 1 06

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

74 participants in 2 patient groups

Treatment-Sequence 1
Other group
Description:
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.
Treatment:
Drug: Reference treatment : Nicotine transdermal patch
Drug: Test treatment : V0116 transdermal patch
Treatment-Sequence 2
Other group
Description:
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.
Treatment:
Drug: Reference treatment : Nicotine transdermal patch
Drug: Test treatment : V0116 transdermal patch

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems