Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.

NCT01234896 NA COMPLETED

Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Details

Lead sponsor	McNeil AB
Phase	NA
Status	COMPLETED
Enrolment	44
Start date	2010-10
Completion	2010-12

Conditions

• Tobacco Dependence

Interventions

• Nicotine Medicated Gum
• 4 mg Nicotine Gum
• 2 mg Nicotine Gum
• 4 mg Nicotine Lozenge

Primary outcomes

• Maximum Observed Plasma Concentration (Cmax) — 12 hours post-dose
  Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
• Area Under the Curve (AUC)(0-t) — 12 hours post-dose
  AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).
• AUC (0-∞) — 12 hours post-dose
  AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Countries

Sweden