Status:
COMPLETED
Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
19-50 years
Phase:
NA
Brief Summary
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
Detailed Description
Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint loz...
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 kilograms per square meter and a total body weight of at least 55.0 kilograms.
- 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 :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01234896
Start Date
October 1 2010
End Date
December 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