NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers | Biotech Hunter

Enrollment

24

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

October 31, 2017

Study Completion Date

October 31, 2017

Conditions

Smoking Cessation

Interventions

DRUG

Nicotine Film

Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.

DRUG

Placebo Nicotine Film

Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.

Trial Locations (1)

17033

Penn State College of Medicine/Milton S. Hershey Medical Center, Hershey