Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
- Registration Number
- NCT01228617
- Brief Summary
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.
- Detailed Description
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A1 Short, no buffer Nicotine Nicotine / not yet marketed A2 Short, low buffer Nicotine Nicotine / not yet marketed A3 Short, high buffer Nicotine Nicotine / not yet marketed B3 Long, high buffer Nicotine Nicotine / not yet marketed R = Nicotine Gum Nicotine Gum Nicorette® Gum B1 Long, no buffer Nicotine Nicotine / not yet marketed B2 Long, low buffer Nicotine Nicotine / not yet marketed
- Primary Outcome Measures
Name Time Method Maximum Concentration Baseline to 10 hours post-dose The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve 10 hours post-dose The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
- Secondary Outcome Measures
Name Time Method Time to Maximum Concentration 10 hours post-dose Time to Maximum Concentration (Tmax)
Residual Nicotine 30 minutes The amount of residual nicotine in the product after being chewed.
Dissolution Time 10 hours post-dose Actual time required for oral dissolution of new NRT products following product administration
Trial Locations
- Locations (1)
Clinical Trial Unit, Clinical Research and Trial Centre
🇸🇪Lund, Sweden