Status:
COMPLETED
Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.
Detailed Description
The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum giv...
Eligibility Criteria
Inclusion
- Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
- 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 :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01234792
Start Date
May 1 2008
End Date
June 1 2008
Last Update
July 10 2012
Active Locations (1)
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1
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20