Status:
COMPLETED
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
Detailed Description
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Re...
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 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01238640
Start Date
August 1 2008
End Date
November 1 2008
Last Update
July 13 2012
Active Locations (1)
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1
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20