An interventional study of 6 mg Experimental nicotine gum and 4 mg Nicotine Gum/ 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 Basic science
Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.
The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 24 is below the median of 90 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:
6 mg Experimental nicotine gum
Drug: 6 mg Experimental nicotine gum
4 mg Nicotine Gum
Drug: 4 mg Nicotine Gum/
2 mg Nicotine Gum
Drug: 2 mg Nicotine Gum
A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
Also known as: Not marketed
A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
Also known as: Nicorette® Gum
A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
Also known as: Nicorette® Gum
Maximum Observed Plasma Concentration (Cmax)
Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
Time frame: During 8 hours post-dose
Area Under the Curve (AUC)(0-t)
AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).
Time frame: During 8 hours post-dose
AUC(0-∞)
AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
Time frame: 8 hours post-dose
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