Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321931
• Other study ID #: NICTDP1081
• Secondary ID: 2010-023026-20
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2011
• Last updated: July 6, 2012
• Start date: February 2011
• Est. completion date: June 2011

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

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Description:

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.

• 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.

• Willing and able to comply with all scheduled visits and study procedures

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.

• Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
• Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
• Nicotine
4 mg marketed nicotine mint lozenge (NIQ)

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	Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Primary	Average Concentration	Average Nicotine Plasma Concentration (Cav) within the last dosing interval	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Primary	Area Under the Curve	Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During 12 hours post-dose	No
Secondary	Minimum Observed Concentration	Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Secondary	Peak-Trough Fluctuation	Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Secondary	Swing	Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin	within the last dosing interval (starting at 10.5-11 hours after first product administration)	No
Secondary	Nicotine Released	The amount of nicotine released from the product during product administration	30 minutes	No