A Single-Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Two-Period Crossover Study to Determine the Bioequivalence of Two Nicotine Resinate Lozenge Formulations Containing Nicotine 2 mg in up to 42 Healthy Male and Female Smokers Under Fasting Conditions

Fertin Pharma A/S1 site in 1 country42 target enrollmentFebruary 19, 2018

ConditionsSmoking Cessation

InterventionsNicotine lozenge

DrugsNicotine lozenge

Overview

Phase: Phase 1
Intervention: Nicotine lozenge
Conditions: Smoking Cessation
Sponsor: Fertin Pharma A/S
Enrollment: 42
Locations: 1
Primary Endpoint: AUC0-t
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 19, 2018

End Date

March 27, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Fertin Pharma A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written consent given for participation in the study.
•Healthy males and females, 18 to 55 years (inclusive) at screening.
•Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
•Body mass not less than 50 kg.
•Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
•Females, if:
•Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: in postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
•Of childbearing potential, the following conditions are to be met:
•Negative pregnancy test
•If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.

Exclusion Criteria

•Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
•Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any IMP substance.
•Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females or evidence of excessive alcohol use as indicated by an alcohol breathalyzer test result ≥ 0.01%.
•Regular exposure to substances of abuse (other than alcohol) within the past year.
•Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
•In this study the concomitant use of hormonal contraceptives is allowed.
•Expired CO levels greater than 10 ppm in the morning prior to dosing.
•History of esophagitis, gastritis, peptic ulcer, gastro-esophageal reflux, gastrointestinal bleeding, rectal bleeding or other clinically significant gastrointestinal abnormalities within past 3 months.
•History of cardiovascular disease such as uncontrolled hypertension, myocardial infarction, stroke or transient ischemic attack within the past 6 months prior to screening, congestive heart failure, angina pectoris, and arrhythmia.
•Evidence of vasospastic disease (i.e., Buerger's disease) on medical history and physical examination.

Arms & Interventions

Nicotine 2 mg mint lozenges

Intervention: Nicotine lozenge

NiQuitin 2 mg mint lozenges

Intervention: Nicotine lozenge

Outcomes

Primary Outcomes

AUC0-t

Time Frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

Area under the plasma concentration versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t)

Cmax

Time Frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

Maximum observed plasma concentration (Cmax)

Secondary Outcomes

Tmax(Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours)
AUC0-inf(Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours)
λz(Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours)
t½.z(Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours)
kel(Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours)