Status:
COMPLETED
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
19-50 years
Phase:
NA
Brief Summary
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Detailed Description
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment vi...
Eligibility Criteria
Inclusion
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (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 :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01152749
Start Date
December 1 2009
End Date
May 1 2010
Last Update
July 10 2012
Active Locations (1)
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1
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20