Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.

NCT01084707 NA COMPLETED Results posted

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Details

Lead sponsor	McNeil AB
Phase	NA
Status	COMPLETED
Enrolment	40
Start date	2009-01
Completion	2009-04

Conditions

• Tobacco Dependence

Interventions

• Oral Nicotine
• Nicotine Lozenge
• Nicotine gum

Primary outcomes

• Maximum Plasma Concentration — During the last dosing interval (hour 11-12 post-dose)
  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)
• Average Concentration — During the last dosing interval (hour 11-12 post-dose)
  Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)

Countries

Sweden