Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
2 other identifiers
interventional
44
1 country
1
Brief Summary
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 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)
12 hours post-dose
Area Under the Curve (AUC)(0-t)
AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).
12 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.
12 hours post-dose
Secondary Outcomes (1)
AUC(10 min)
10 minutes post-dose
Study Arms (4)
Nicotine Gum 6
EXPERIMENTAL6 mg Nicotine medicated gum
Nicotine Gum 4
ACTIVE COMPARATOR4 mg Nicotine Gum
Nicotine Gum 2
ACTIVE COMPARATOR2 mg Nicotine Gum
Nicotine Lozenge
ACTIVE COMPARATOR4 mg Nicotine Lozenge
Interventions
Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved
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
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
July 10, 2012
Record last verified: 2012-07