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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
Details
| Lead sponsor | McNeil AB |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2009-03 |
| Completion | 2009-06 |
Conditions
- Tobacco Dependence
Interventions
- Oral Nicotine
- NiQuitinTM Nicotine Lozenge
- Nicorette® Nicotine Gum
Primary outcomes
- Maximum Plasma Concentration — During 12 hours after start of administration
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml) - Bioavailability — 12 hours
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).
Countries
Sweden