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Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
Details
| Lead sponsor | McNeil AB |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 104 |
| Start date | 2009-08 |
| Completion | 2010-01 |
Conditions
- Tobacco Dependence
Interventions
- Experimental Nicotine Replacement Therapy (NRT) 2 mg
- Experimental Nicotine Replacement Therapy (NRT)
- Marketed Nicotine Lozenge
- Marketed Nicotine Lozenge
Primary outcomes
- Maximum Plasma Concentration — during 12 hours after product administration
The maximum observed nicotine concentration in plasma (Cmax) - Area under the Curve — after 12 hours
The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Countries
Sweden