Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Single-dose Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum. A Study in Healthy Smokers.
2 other identifiers
interventional
28
1 country
1
Brief Summary
Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedJuly 10, 2012
July 1, 2012
2 months
June 28, 2010
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic measurements
Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Baseline and during 8 hours after product administration
Secondary Outcomes (3)
tmax
During 8 hours after start of product administration
Lamda z
During 8 hours after start of product administration
Released amount of nicotine
After 30 minutes of chewing
Study Arms (3)
UNG-GA
EXPERIMENTALNew NRT product
UNG-GB
EXPERIMENTALNew NRT product
Nicorette® Gum
ACTIVE COMPARATORNicorette® Gum
Interventions
2 mg, Single Dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (1)
McNeil AB Clinical Pharmacology R&D
Lund, SE-222 20, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
March 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
July 10, 2012
Record last verified: 2012-07