Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Tobacco Dependence Clinical Trial

Official title:

Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227720
• Other study ID #: NICTDP1076
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: July 6, 2012
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Experimental Nicotine Replacement Therapy (NRT) 2 mg
2 mg Single-dose of new NRT product (NSL2L)
• Experimental Nicotine Replacement Therapy (NRT)
4 mg Single-dose of new NRT product
• Marketed Nicotine Lozenge
2 mg Single-dose of marketed lozenge
• Marketed Nicotine Lozenge
4 mg Single-dose of marketed lozenge

Locations

Country	Name	City	State
Sweden	Lund University Hospital Clinical Trial Unit	Lund
Sweden	McNeil AB Clinical Pharmacology R&D	Lund

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration	The maximum observed nicotine concentration in plasma (Cmax)	during 12 hours after product administration	No
Primary	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 (AUC8)	after 12 hours	No
Secondary	Time of Maximum Concentration	The time of occurrence of maximum concentration (Tmax)	during 12 hours after start of product administration	No
Secondary	Terminal Elimination Rate Constant	The terminal nicotine elimination rate constant (?z)	during 12 hours after start of product administration	No
Secondary	Oral Dissolution Time	Actual time required for oral dissolution	from administration until completely dissolved	No