|
Main
|
|
Note: This record shows only 22 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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01228617 |
|
Date of registration:
|
25/10/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
|
|
Scientific title:
|
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers |
|
Date of first enrolment:
|
September 2007 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01228617 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Contacts
|
|
Name:
|
Elisabeth Kruse, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
McNeil AB |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Healthy smokers, smoking at least 10 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 month
preceding the first dose of study medication.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tobacco Dependence
|
|
Intervention(s)
|
|
Drug: Nicotine
|
|
Drug: Nicotine Gum
|
|
Primary Outcome(s)
|
|
Maximum Concentration
[Time Frame: Baseline to 10 hours post-dose]
|
|
Area under the Curve
[Time Frame: 10 hours post-dose]
|
|
Secondary Outcome(s)
|
|
Residual Nicotine
[Time Frame: 30 minutes]
|
|
Dissolution Time
[Time Frame: 10 hours post-dose]
|
|
Time to Maximum Concentration
[Time Frame: 10 hours post-dose]
|
|
Secondary ID(s)
|
|
A6431114-NICTDP1063
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|