Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Tobacco Dependence Clinical Trial

Official title:

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152749
• Other study ID #: NICTDP1075
• Secondary ID: 2009-010633-44
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: July 6, 2012
• Start date: December 2009
• Est. completion date: May 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

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Description:

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• 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 body mass index (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: Bio-equivalence 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
Single-dose of new NRT product
• Nicotine Gum
Single-dose of marketed nicotine gum

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 10 hours after product administration	No
Secondary	tmax	The time of occurrence of Cmax following product administration	Baseline and during 10 hours after product administration	No
Secondary	Lamda z	The terminal nicotine elimination rate constant (?z)	Baseline and during 10 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