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Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.
Details
| Lead sponsor | McNeil AB |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2011-02 |
| Completion | 2011-06 |
Conditions
- Tobacco Dependence
Interventions
- Nicotine
- Nicotine
- Nicotine
Primary outcomes
- Maximum Observed Plasma Concentration — within the last dosing interval (starting at 10.5-11 hours after first product administration)
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL) - Average Concentration — within the last dosing interval (starting at 10.5-11 hours after first product administration)
Average Nicotine Plasma Concentration (Cav) within the last dosing interval - Area Under the Curve — within the last dosing interval (starting at 10.5-11 hours after first product administration)
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
Countries
Sweden