Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
2 mg Single-dose
McNeil AB Clinical Pharmacology R&D
Lund, Sweden
Pharmacokinetic measurements
Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Time frame: Baseline and during 8 hours after product administration
tmax
The time of occurrence of Cmax following product administration
Time frame: Baseline and during 8 hours after product administration
Lamda z
The terminal nicotine elimination rate constant (λz)
Time frame: Baseline and during 8 hours after product administration
Released amount of nicotine
The amount of nicotine released from gums during 30 minutes' chewing
Time frame: After 30 minutes of chewing
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