An interventional study of Nicotine in Tobacco Dependence, sponsored by McNeil AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by McNeil AB · Not applicable, Interventional, and Treatment
Single-dose pharmacokinetics with two new oral nicotine replacement products 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 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 and study personnel.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 28 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →McNeil AB is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
New NRT product
Drug: Nicotine
New NRT product
Drug: Nicotine
Nicorette® Gum
Drug: Nicotine
2 mg, Single Dose
Also known as: Experimental NRT UNG-GA and UNG-GB, and Nicorette® Gum
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: During 8 hours after start of product administration
Lamda z
The terminal nicotine elimination rate constant (λz)
Time frame: During 8 hours after start of product administration
Released amount of nicotine
The amount of nicotine released from gums during 30 minutes' chewing.
Time frame: After 30 minutes of chewing
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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McNeil AB