Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

• Status: Completed
• Trial end date: 2017-11-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.

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

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Collaborator: Rose Research Center, LLC
• Treatments: Nicotine

Criteria

Inclusion Criteria:

1. Participants have to be 18-45 years old

2. Participants must provide written informed consent prior to any study related procedures being performed.

3. Participants must have a willingness and ability to comply with the protocol requirements.

4. Participants must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)

5. 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.

6. Participants must consume more than 10 cigarettes daily and Fagerström Test for Nicotine Dependence score of 4 or greater.

7. Participants must have no intention of quitting smoking in the next 60 days.

Exclusion Criteria:

1. 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.

2. Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.

3. Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.

4. Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.

5. Volunteers with diagnosed stomach ulcers.

6. Volunteers who are taking insulin for diabetes.

7. Volunteers with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic.

8. Volunteers who are unable to fulfill the visit schedule

9. Volunteers who have severe allergic history

10. Volunteers who have known intolerance to medication

11. Volunteers who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases

12. Volunteers who had surgical operations on gastrointestinal tract with the exception of appendectomy

13. Volunteers who donated 450 mL and more of his/her blood or blood plasma within the last 2 months prior to the study entry

14. Volunteers who meet criteria for dependence on a substance other than nicotine.

15. Participants having a body mass index below 18 or over 35.