Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers
2 other identifiers
interventional
24
1 country
1
Brief Summary
Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.
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 May 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
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedJuly 10, 2012
July 1, 2012
1 month
November 3, 2010
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax)
Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
During 8 hours post-dose
Area Under the Curve (AUC)(0-t)
AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).
During 8 hours post-dose
AUC(0-∞)
AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
8 hours post-dose
Study Arms (3)
NIC-6
EXPERIMENTAL6 mg Experimental nicotine gum
NIC-4
ACTIVE COMPARATOR4 mg Nicotine Gum
NIC-2
ACTIVE COMPARATOR2 mg Nicotine Gum
Interventions
A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 4, 2010
Study Start
May 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 10, 2012
Record last verified: 2012-07