Status:
COMPLETED
Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge
Lead Sponsor:
Pharmaceutical Productions Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Pharmacokinetic Study
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 Kl...
Detailed Description
A single oral dose of each medication will be administered to each participant with a 48 hour washout period between administrations. Serial blood samples will be obtained at the following times after...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01887847
Start Date
June 1 2013
End Date
August 1 2014
Last Update
March 30 2016
Active Locations (1)
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1
Friends Research Institute Clinic
Torrance, California, United States, 90502