Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers
2 other identifiers
interventional
88
1 country
1
Brief Summary
Bioequivalence between 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 P50-P75 for not_applicable
Started Sep 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
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedJuly 10, 2012
July 1, 2012
2 months
April 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 (AUCinf)
Baseline and during 10 hours after product administration
Secondary Outcomes (4)
Tmax
during 10 hours after start of product administration
λz
during 10 hours after start of product administration
Residual Nicotine
After 30 minutes of chewing
Dissolution Time
From product administration until completely dissolved
Study Arms (4)
NRT-2
EXPERIMENTAL2 mg single-dose of a new NRT product
GUM-2
ACTIVE COMPARATOR2 mg single-dose of a marketed nicotine gum
NRT-4
EXPERIMENTAL4 mg single-dose of a new NRT product
GUM-4
ACTIVE COMPARATOR4 mg single-dose of marketed nicotine gum
Interventions
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
Single-dose of marketed nicotine gum 2 mg or 4 mg
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)
Berzelius Clinical Research Center
Linköping, SE-582 25, 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
April 29, 2010
Study Start
September 1, 2008
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
July 10, 2012
Record last verified: 2012-07