The purpose of the study is to compare two different dosage forms from which nicotine is
released and absorbed into the bloodstream.
Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg
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Locations near you
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Full eligibility criteria for NCT02906995
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Participants have to be 18-45 years old
Participants must provide written informed consent prior to any study related procedures being performed.
Participants must have a willingness and ability to comply with the protocol requirements.
Participants must be in good health and free from any clinically significant pathology
(gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)
Female participants of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
Participants must consume more than 10 cigarettes daily and Fagerström Test for Nicotine Dependence score of 4 or greater.
Participants must have no intention of quitting smoking in the next 60 days.
Volunteers that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc within 30 days of study entry.
Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.
Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.
Volunteers with diagnosed stomach ulcers.
Volunteers who are taking insulin for diabetes.
Volunteers with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic.
Volunteers who are unable to fulfill the visit schedule
Volunteers who have severe allergic history
Volunteers who have known intolerance to medication
Volunteers who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
Volunteers who had surgical operations on gastrointestinal tract with the exception of appendectomy
Volunteers who donated 450 mL and more of his/her blood or blood plasma within the last 2 months prior to the study entry
Volunteers who meet criteria for dependence on a substance other than nicotine.
Participants having a body mass index below 18 or over 35.
All locations for NCT02906995
United States (1)
Rose Research Center
Raleigh, North Carolina, United States, 27617
View full eligibility
Tris trial is registered with FDA with number: NCT02906995. The sponsor of the trial is Friends Research Institute, Inc. and it is looking for 24 volunteers for the current phase.
Official trial 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
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