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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmaceutical Productions Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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