A Single-Center, Randomized, Open-Label, Two-Period, Cross Over, Pharmacokinetic Study to Assess the Relative Bioavailability of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS1) versus NicoDerm (Registered Trademark) CQ (Registered Trademark) Patch

Nicotine Replacement Therapy System Dosing period consists of 3 days with approximately 21 mg of nicotine delivered transdermally per day using the Chrono Quit Smoking Solution (CQSS1). Doses of 5.4% nicotine formulation delivered transdermally via the CQSS1 worn either on the upper arm or mid-thigh at programmed intervals of T0 (upon waking in the morning), T0.5, T1, T7, T7.5, and T13 hours each day. The dosing timepoints are consistent across 3 consecutive days. Each CQSS1 is worn for 24 hours and is changed once daily upon waking. The washout period between study treatments is 2 days. Participants are required to stay in the clinic for 8 days. The treatment will not be titrated. The treatment will be adapted to subject’s wake-up time. The CQSS1 treatments will be administered by the health care provider. Placement of the CQSS1 on the subject will be randomized to mid-thigh and taped, upper arm and taped, mid-thigh not taped, upper arm not taped. Additionally, subjects will be randomized to the sequence CQSS1 then NicoDerm or NicoDerm then CQSS1. Body location and taping status will remain the same throughout the study for each subject. Pharmacokinetic and skin irritation assessment using an 8-point visual scale will be used.