Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Tobacco Dependence Clinical Trial

Official title:

Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234792
• Other study ID #: NICTDP1070
• Secondary ID: 2008-000596-15
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: July 6, 2012
• Start date: May 2008
• Est. completion date: June 2008

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 nicotine pharmacokinetics with three oral nicotine replacement products.

Description:

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.

• 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, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• 6 mg Experimental nicotine gum
A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
• 4 mg Nicotine Gum/
A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
• 2 mg Nicotine Gum
A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

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	Maximum Observed Plasma Concentration (Cmax)	Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)	During 8 hours post-dose	No
Primary	Area Under the Curve (AUC)(0-t)	AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).	During 8 hours post-dose	No
Primary	AUC(0-8)	AUC(0-8), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.	8 hours post-dose	No