Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

Tobacco Dependence Clinical Trial

Official title:

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152736
• Other study ID #: NICTDP1073
• Secondary ID: 2008-005520-87
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: July 6, 2012
• Start date: November 2008
• Est. completion date: January 2009

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

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

Description:

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine
2 mg Single-dose

Locations

Country	Name	City	State
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	Pharmacokinetic measurements	Pharmacokinetic measurements including: the maximum observed nicotine concentration in plasma (Cmax); the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt); the area under the plasma concentration-vs.-time curve until infinity (AUC8)	Baseline and during 8 hours after product administration	No
Secondary	tmax	The time of occurrence of Cmax following product administration	Baseline and during 8 hours after product administration	No
Secondary	Lamda z	The terminal nicotine elimination rate constant (?z)	Baseline and during 8 hours after product administration	No
Secondary	Released amount of nicotine	The amount of nicotine released from gums during 30 minutes' chewing	After 30 minutes of chewing	No