Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg; Drug: Marketed Nicotine Lozenge; Drug: Experimental Nicotine Replacement Therapy (NRT)

• Registration Number: NCT01227720
• Lead Sponsor: McNeil AB

Brief Summary

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
• Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

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Exclusion Criteria

• Pregnancy, lactation or intended pregnancy.
• Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A NSL2L	Experimental Nicotine Replacement Therapy (NRT) 2 mg	Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg
B Lozenge	Marketed Nicotine Lozenge	Marketed Nicotine Lozenge 2 mg
C NSL4M	Experimental Nicotine Replacement Therapy (NRT)	Experimental NRT (M) 4 mg
D Lozenge	Marketed Nicotine Lozenge	Marketed Nicotine Lozenge 4 mg
E NSL4L	Experimental Nicotine Replacement Therapy (NRT)	Experimental NRT (L) 4 mg
F NSL4H	Experimental Nicotine Replacement Therapy (NRT)	Experimental NRT (H) 4 mg

Primary Outcome Measures

Name	Time	Method
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∞)

Secondary Outcome Measures

Name	Time	Method
Time of Maximum Concentration	during 12 hours after start of product administration	The time of occurrence of maximum concentration (Tmax)
Terminal Elimination Rate Constant	during 12 hours after start of product administration	The terminal nicotine elimination rate constant (λz)
Oral Dissolution Time	from administration until completely dissolved	Actual time required for oral dissolution

Trial Locations

Locations (2)

Lund University Hospital Clinical Trial Unit; 🇸🇪 Lund, Sweden

McNeil AB Clinical Pharmacology R&D; 🇸🇪 Lund, Sweden