Status:
COMPLETED
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01228617
Start Date
September 1 2007
End Date
October 1 2007
Last Update
October 6 2011
Active Locations (1)
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1
Clinical Trial Unit, Clinical Research and Trial Centre
Lund, Sweden, SE-221 85