Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084603
• Other study ID #: NICTDP1065/A6431116
• Secondary ID: 2008-006280-36
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: July 6, 2012
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Description:

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy smokers, smoking at least 15 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 months 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:
• Oral Nicotine
A new l mg oral nicotine product
• NiQuitinTM Nicotine Lozenge
A marketed 4 mg Nicotine lozenge
• Nicorette® Nicotine Gum
A marketed 4 mg Nicotine Gum

Locations

Country	Name	City	State
Sweden	Clinical Pharmacology	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	Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)	During 12 hours after start of administration	No
Primary	Bioavailability	A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).	12 hours	No
Secondary	Nicotine Plasma Concentration	Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)	During 10 minutes after start of administration	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During 12 hours after start of administration	No
Secondary	Terminal Elimination Rate Constant	The terminal nicotine elimination rate constant (Lamda z)	During 12 hours after start of administration	No
Secondary	Released Nicotine	The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing	After 30 minutes' chewing	No