Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
2 other identifiers
interventional
76
1 country
1
Brief Summary
This study examines the bioequivalence between an oral nicotine replacement product 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 Dec 2009
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
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
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
3 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 10 hours after product administration
Secondary Outcomes (3)
tmax
Baseline and during 10 hours after product administration
Lamda z
Baseline and during 10 hours after product administration
Released amount of nicotine
After 30 minutes of chewing
Study Arms (4)
UNG-GC-2
EXPERIMENTAL2 mg experimental NRT product
UNG-GC-4
EXPERIMENTAL4 mg experimental NRT product
Nicorette® Gum-2
ACTIVE COMPARATOR2 mg Nicorette® Gum
Nicorette® Gum-4
ACTIVE COMPARATOR4 mg Nicorette® Gum
Interventions
Single-dose of new NRT product
Single-dose of marketed nicotine gum
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
December 1, 2009
Primary Completion
March 1, 2010
Study Completion
May 1, 2010
Last Updated
July 10, 2012
Record last verified: 2012-07