Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084707
• Other study ID #: NICTDP1066-A6431117
• Secondary ID: 2008-006279-65
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: July 6, 2012
• Start date: January 2009
• Est. completion date: April 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 multiple-doses 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 steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 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: 40
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy smokers, smoking at least 20 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.

• Prior regular use of nicotine mouth spray

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
Oral Nicotine either self-administered or provided by study personnel within 12 hours
• Nicotine Lozenge
Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
• Nicotine gum
Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

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 the last dosing interval (hour 11-12 post-dose)	No
Primary	Average Concentration	Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)	During the last dosing interval (hour 11-12 post-dose)	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During the last dosing interval (hour 11-12 post-dose)	No
Secondary	Minimum Plasma Concentration	The minimum nicotine plasma concentration during the last dosing interval (Cmin)	During the last dosing interval (hour 11-12 post-dose)	No
Secondary	Peak-Trough Fluctuation	Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)	During the last dosing interval (hour 11-12 post-dose)	No
Secondary	Nicotine Plasma Concentration	The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment	One hour after start of treatment	No