Status:
COMPLETED
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
19-50 years
Phase:
NA
Brief Summary
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
Detailed Description
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nic...
Eligibility Criteria
Inclusion
- Healthy subjects, 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 :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01227720
Start Date
August 1 2009
End Date
January 1 2010
Last Update
July 10 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Lund University Hospital Clinical Trial Unit
Lund, Sweden, SE-221 85
2
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20