Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
- Registration Number
- NCT01321931
- Lead Sponsor
- McNeil AB
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NFG 60 Nicotine A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits NRT 60 Nicotine A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits NIQ 60 Nicotine A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits NFG 90 Nicotine A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits NRT 90 Nicotine A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration within the last dosing interval (starting at 10.5-11 hours after first product administration) 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)
Average Concentration within the last dosing interval (starting at 10.5-11 hours after first product administration) Average Nicotine Plasma Concentration (Cav) within the last dosing interval
Area Under the Curve within the last dosing interval (starting at 10.5-11 hours after first product administration) Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
- Secondary Outcome Measures
Name Time Method Time of Maximum Concentration During 12 hours post-dose The time at which maximum concentration is reached (Tmax)
Minimum Observed Concentration within the last dosing interval (starting at 10.5-11 hours after first product administration) 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)
Peak-Trough Fluctuation within the last dosing interval (starting at 10.5-11 hours after first product administration) Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)
Swing within the last dosing interval (starting at 10.5-11 hours after first product administration) Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin
Nicotine Released 30 minutes The amount of nicotine released from the product during product administration
Trial Locations
- Locations (1)
McNeil AB Clinical Pharmacology R&D
🇸🇪Lund, Sweden