Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.
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 Sep 2007
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, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedJuly 10, 2012
July 1, 2012
2 months
November 9, 2010
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax)
Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
During 10 hours post-dose
Area Under the Curve (AUC)(0-t)
Bioavailability within the Set Period \[AUC(0-t)\] 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).
During 10 hours post-dose
AUC(0-∞)
AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).
10 hours post-dose
Secondary Outcomes (1)
Product Dissolution Time
During 10 hours post-dose
Study Arms (4)
Nicotine Sublingual Tablet Mint (NSTM)-2
EXPERIMENTALExperimental 2 mg NSTM
Microtab-2
ACTIVE COMPARATOR2 mg Nicotine tablet
NSTM-4
EXPERIMENTALExperimental 4 mg Nicotine Sublingual Tablet Mint
Microtab-4
ACTIVE COMPARATOR2 x 2 mg Nicotine tablet
Interventions
A single dose of an experimental NSTM, with a 36-hour washout between visits
A single dose of a marketed Nicotine Replacement Therapy (NRT), 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 months 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 10, 2010
Study Start
September 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
July 10, 2012
Record last verified: 2012-07