Clinical trial NCT01321931: Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
Official title: Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
measure: Average Concentration
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
measure: Area Under the Curve
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Secondary outcomes:
measure: Time of Maximum Concentration
timeFrame: During 12 hours post-dose
measure: Minimum Observed Concentration
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
measure: Peak-Trough Fluctuation
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
measure: Swing
timeFrame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
measure: Nicotine Released
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References: