Status:
COMPLETED
Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
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 oral nicotine sublingual tablets, 2 mg and 4 mg.
Detailed Description
The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT),...
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 months preceding the first dose of study medication.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01238627
Start Date
September 1 2007
End Date
November 1 2007
Last Update
July 10 2012
Active Locations (1)
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1
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20