Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

Completed · Phase 1

Conditions studied: Nicotine Pharmacokinetic Study

In brief

The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

Key facts

Study ID

NCT01887847

Run by

Pharmaceutical Productions Inc.

People needed

6

Starts

2013-06-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-30

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects have to be 18-45 years old
• Subjects must provide written informed consent prior to any study related procedures being performed.
• Subjects must have a willingness and ability to comply with the protocol requirements.
• Subjects must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, central nervous system diseases)
• Subjects must have body mass index not to exceed 35
• Female subjects 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.
• Subjects must consume more than 15 cigarettes daily and smoke their first cigarette within 30 minutes of awaking from sleeping.
• A Fagerstrom Smoking index greater than 4

You may not qualify if…

• Subjects 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.
• Subjects who have smoked any substance other than tobacco within 30 days of study entry.
• Subjects that have used other smoking cessation aids (including bupropion, herbals, counseling, etc.) within 30 days of study entry.
• Subjects who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
• Subject who is pregnant or lactating, or planned to became pregnant within 6 months.
• Subjects who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a heart attack.
• Subject with diagnosed stomach ulcers.
• Subjects who have taking insulin for diabetes.
• Subjects with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic
• Subjects who are unable to fulfill study requirements in relation to conforming to the visit schedule.
• Subjects who have severe allergic history
• Subjects who have known intolerance to medication
• Subjects who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
• Subjects who had surgical operations on gastrointestinal tract with the exception of appendectomy
• Subjects who had acute infectious diseases within the last 4 weeks prior to the study entry;
• Subjects who donated 450 mL and more of his/her blood or blood plasma within the last 2 month prior to the study entry
• Subjects who are taking more than 10 units of alcohol per week or have a history of alcohol and drug abuse

Where it is running

• Friends Research Institute Clinic — Torrance, California, United States

Full record on ClinicalTrials.gov

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