Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Tobacco Dependence Clinical Trial

Official title:

Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113424
• Other study ID #: NICTDP1071
• Secondary ID: 2008-003358-14
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: July 6, 2012
• Start date: September 2008
• Est. completion date: December 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

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Description:

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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: 88
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy smokers, 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: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
• Nicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg

Locations

Country	Name	City	State
Sweden	Berzelius Clinical Research Center	Linköping

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 (AUCinf)	Baseline and during 10 hours after product administration	No
Secondary	Tmax	The time of occurrence of Cmax (tmax) following product administration	during 10 hours after start of product administration	No
Secondary	?z	The terminal nicotine elimination rate constant (?z)	during 10 hours after start of product administration	No
Secondary	Residual Nicotine	The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.	After 30 minutes of chewing	No
Secondary	Dissolution Time	Actual time required for oral dissolution of new NRT products following product administration	From product administration until completely dissolved	No