Clinical Trials/NCT02356913

NCT02356913

Completed

Phase 1

A Pilot, Open Label, Randomised, Single Dose, Four-Period, Four-Treatment, Four-Sequence, Four Way Crossover Comparative Pharmacokinetic Study of Three Different 4 mg Nicotine Chewing Gum Test Formulations of Fertin Pharma A/S, Denmark With Nicorette Freshmint 4 mg Medicated Chewing Gum of McNeil Denmark ApS as Reference Formulation in Healthy, Adult, Human Smokers Under Fasting Conditions

Fertin Pharma A/S0 sites15 target enrollmentApril 2014

ConditionsSmoking Cessation

InterventionsNicotine gum

DrugsNicotine gum

Overview

Phase: Phase 1
Intervention: Nicotine gum
Conditions: Smoking Cessation
Sponsor: Fertin Pharma A/S
Enrollment: 15
Primary Endpoint: The area under the plasma concentration vs. time curve until the last measurable concentration (AUC0-t)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between three new nicotine gum formulations and a reference nicotine gum in healthy smokers.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Fertin Pharma A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, adult, human smoker volunteers of any race within the age between 18 to 55 years.
•Willingness to provide informed consent to participate in the study
•Body Mass Index (BMI)\> 18.5 kg/m2 to \< 28.0 kg/m
•Smoke 5-10 cigarettes per day continuously for the last three (3) months
•Exhaled carbon monoxide ≥ 10 ppm at screening visit
•Successfully complete the training session
•Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs as deemed by the Clinical Investigator
•Subject who are not in the process of quitting smoking
•Hemoglobin: ≥12.0 gm% for male and ≥11.5 gm% for female
•Absence of disease markers of HIV I \& II, HBsAg, HCVAb and P24 antigen test.

Exclusion Criteria

•History or presence of; drug abuse within the past year; hypersensitivity or idiosyncratic reaction to Nicotine or the resin of the gum preparation; any form of oral and/or pharyngeal inflammation; any form of oral lesions and/or gum disease or temperomandibular joint dysfunction; dentures or any dental work that could, in the opinion of the Investigator, affect the conduct of the study (including missing molars);
•Any major illness in the last three months or any significant ongoing chronic medical illness.
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
•Active deep vein thrombosis, arterial thromboembolic disorders or a history of these conditions
•History of or current gastro-intestinal diseases influencing drug absorption.
•Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
•Those who have used tobacco or nicotine containing products within 24 hours prior to the study drug administration on each study day.
•Subjects with carbon monoxide levels greater than or equal to 8 ppm in the morning prior to dosing.
•Suffer from xerostomia (dry mouth).
•Subjects using any smoking cessation aids such as nicotine replacement therapy (NRT), buproprion or varenicline during the last 3 months.

Arms & Interventions

Gum B

4 mg nicotine gum; single dose; chewed 30 minutes

Intervention: Nicotine gum

Gum A

4 mg nicotine gum; single dose; chewed 30 minutes

Intervention: Nicotine gum

Gum C

4 mg nicotine gum; single dose; chewed 30 minutes

Intervention: Nicotine gum

Nicorette Freshmint

4 mg nicotine gum; single dose; chewed 30 minutes

Intervention: Nicotine gum

Outcomes

Primary Outcomes

The area under the plasma concentration vs. time curve until the last measurable concentration (AUC0-t)

Time Frame: 12 hours

The area under the plasma concentration vs. time curve until infinity (AUC∞)

Time Frame: 12 hours

The maximum observed nicotine concentration in plasma (Cmax)

Time Frame: 12 hours

Secondary Outcomes

Tmax(12 hours from start of product administration)
Kel(12 hours)
T½(12 hours)
The amount of nicotine released from the gum during 30 minutes of chewing(30 minutes)