An interventional study of Experimental Nicotine Replacement Therapy (NRT) 2 mg and Experimental Nicotine Replacement Therapy (NRT) in Tobacco Dependence, sponsored by McNeil AB. Completed at 2 sites in Sweden. Open to participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by McNeil AB · Not applicable, Interventional, and Treatment
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 104 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →McNeil AB is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg
Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg
Marketed Nicotine Lozenge 2 mg
Drug: Marketed Nicotine Lozenge
Experimental NRT (M) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
Marketed Nicotine Lozenge 4 mg
Drug: Marketed Nicotine Lozenge
Experimental NRT (L) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
Experimental NRT (H) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
2 mg Single-dose of new NRT product (NSL2L)
Also known as: Not yet marketed
4 mg Single-dose of new NRT product
Also known as: Not yet marketed
2 mg Single-dose of marketed lozenge
Also known as: NiQuitin™ lozenge
4 mg Single-dose of marketed lozenge
Also known as: NiQuitin™ lozenge
Maximum Plasma Concentration
The maximum observed nicotine concentration in plasma (Cmax)
Time frame: during 12 hours after product administration
Area under the Curve
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∞)
Time frame: after 12 hours
Time of Maximum Concentration
The time of occurrence of maximum concentration (Tmax)
Time frame: during 12 hours after start of product administration
Terminal Elimination Rate Constant
The terminal nicotine elimination rate constant (λz)
Time frame: during 12 hours after start of product administration
Oral Dissolution Time
Actual time required for oral dissolution
Time frame: from administration until completely dissolved
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McNeil AB