Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-03 @ 9:01 PM
Study NCT ID:
NCT02906995
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers
Sponsor:
Friends Research Institute, Inc.
Organization:
Study Overview
Official Title:
An Open-Label Pseudorandomized, Two Way Crossover Comparison of the Single-Dose Pharmacokinetics of Nicotine 4 mg Sublingual Tablets Versus Nicorette Lozenge 4 mg in Healthy Smokers Under Fasted Conditions
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.
Detailed Description:
Objective The primary objective of this study is to determine the pharmacokinetic profile of a single dose of Nicotine Sublingual Tablets, 4 mg (Test Product) versus Nicorette Lozenge 4 mg in healthy adult smokers when administered under fasted conditions.
Study Design This is an open-label, pseudorandomized, two-way crossover comparison of the 4 mg sublingual nicotine tablet versus the Nicorette Lozenge 4 mg.
Number of Subjects Twenty-four (24) healthy adult smokers will be enrolled. Screening Procedures Demographic data, medical and medication histories, physical examination, measurement of height and weight, electrocardiogram (ECG), vital signs (blood pressure, heart rate, body temperature and respiratory rate), hematology, chemistry, urinalysis, end-expired Carbon Monoxide, and serum pregnancy test (for female subjects only) .
Confinements Subjects will be confined approximately 2 hours or earlier prior to study drug administration until after discharge vital signs and the 240 minute (min) post-dose blood draw and End-of-Study (EOS) procedures.
Study Drug Administration A single dose of Test Product (Nicotine Sublingual Tablets, 4 mg) and Nicorette Lozenge 4 mg will be administered to each subject in the study.
Sample Collection A total of 14 blood samples will be obtained per period. Samples will be taken pre-dose (up to 90 minutes prior to dose) and 3, 6, 9, 12, 15, 20 30, 45, 60, 90, 120, 180 and 240 minutes post-dose. A minimum of 48 hours will transpire between dose administrations.
Safety Assessments Vital signs (blood pressure, heart rate, body temperature and respiratory rate) will be measured before administration of study drug. The following will be performed at check-in: urine pregnancy test (for female subjects only). Ongoing monitoring for adverse events (AEs) will be performed during the study. Prior to release from the clinic, a well-being assessment and discharge vital signs will be completed 240 minutes (±60 min) post dosing or at Early Termination (ET).
End of Study (EOS) or Early Termination (ET) Procedures Vital signs and monitoring for AEs will be done 240 min post-dosing or at ET/withdrawal prior to release from clinic.
Analytical Method Plasma concentrations of nicotine will be determined using a validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Pharmacokinetics/Pharmacodynamics Determination of primary parameters Area under the curve ( AUC0-t, AUC0-inf), concentration maximum (Cmax), Time to maximum concentration(Tmax) and secondary parameters such as plasma elimination half-life( t1/2) using a by non-linear kinetics program (WinNonlin®). Pharmacodynamics effects will be measured by taking the heart rate and blood pressure will be taken three times in the first 30 minutes after test product administration. A craving assessment will be obtained at 1, 3, 7, 11, and 14 minutes post-medication administration.
Statistical Analyses No formal statistical analyses are planned; descriptive statistics of the concentration and pharmacokinetic data on nicotine will be provided. Exploratory analyses of craving reductions will be conducted.
Study Design This is an open-label, pseudorandomized, two-way crossover comparison of the 4 mg sublingual nicotine tablet versus the Nicorette Lozenge 4 mg.
Number of Subjects Twenty-four (24) healthy adult smokers will be enrolled. Screening Procedures Demographic data, medical and medication histories, physical examination, measurement of height and weight, electrocardiogram (ECG), vital signs (blood pressure, heart rate, body temperature and respiratory rate), hematology, chemistry, urinalysis, end-expired Carbon Monoxide, and serum pregnancy test (for female subjects only) .
Confinements Subjects will be confined approximately 2 hours or earlier prior to study drug administration until after discharge vital signs and the 240 minute (min) post-dose blood draw and End-of-Study (EOS) procedures.
Study Drug Administration A single dose of Test Product (Nicotine Sublingual Tablets, 4 mg) and Nicorette Lozenge 4 mg will be administered to each subject in the study.
Sample Collection A total of 14 blood samples will be obtained per period. Samples will be taken pre-dose (up to 90 minutes prior to dose) and 3, 6, 9, 12, 15, 20 30, 45, 60, 90, 120, 180 and 240 minutes post-dose. A minimum of 48 hours will transpire between dose administrations.
Safety Assessments Vital signs (blood pressure, heart rate, body temperature and respiratory rate) will be measured before administration of study drug. The following will be performed at check-in: urine pregnancy test (for female subjects only). Ongoing monitoring for adverse events (AEs) will be performed during the study. Prior to release from the clinic, a well-being assessment and discharge vital signs will be completed 240 minutes (±60 min) post dosing or at Early Termination (ET).
End of Study (EOS) or Early Termination (ET) Procedures Vital signs and monitoring for AEs will be done 240 min post-dosing or at ET/withdrawal prior to release from clinic.
Analytical Method Plasma concentrations of nicotine will be determined using a validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Pharmacokinetics/Pharmacodynamics Determination of primary parameters Area under the curve ( AUC0-t, AUC0-inf), concentration maximum (Cmax), Time to maximum concentration(Tmax) and secondary parameters such as plasma elimination half-life( t1/2) using a by non-linear kinetics program (WinNonlin®). Pharmacodynamics effects will be measured by taking the heart rate and blood pressure will be taken three times in the first 30 minutes after test product administration. A craving assessment will be obtained at 1, 3, 7, 11, and 14 minutes post-medication administration.
Statistical Analyses No formal statistical analyses are planned; descriptive statistics of the concentration and pharmacokinetic data on nicotine will be provided. Exploratory analyses of craving reductions will be conducted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: