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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01084603 |
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Date of registration:
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09/03/2010 |
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Primary sponsor: |
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Public title:
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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
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Scientific title:
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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01084603 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Elisabeth Kruse, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McNeil AB |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy smokers, smoking at least 15 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco Dependence
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Intervention(s)
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Drug: Nicorette® Nicotine Gum
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Drug: NiQuitinTM Nicotine Lozenge
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Drug: Oral Nicotine
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Primary Outcome(s)
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Bioavailability
[Time Frame: 12 hours]
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Maximum Plasma Concentration
[Time Frame: During 12 hours after start of administration]
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Secondary Outcome(s)
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Nicotine Plasma Concentration
[Time Frame: During 10 minutes after start of administration]
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Released Nicotine
[Time Frame: After 30 minutes' chewing]
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Terminal Elimination Rate Constant
[Time Frame: During 12 hours after start of administration]
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Time of Maximum Concentration
[Time Frame: During 12 hours after start of administration]
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Secondary ID(s)
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2008-006280-36
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NICTDP1065/A6431116
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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