- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152749
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
July 6, 2012 updated by: McNeil AB
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments).
The investigational products will be given as single doses at separate treatment visits.
Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits.
Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration.
Used gums will be collected and analyzed to determine the amount of remaining nicotine.
Subjects will also be monitored to capture any adverse events that may occur.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, SE-222 20
- McNeil AB Clinical Pharmacology R&D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (BMI) between 17.5 and 30.0 kg/m2.
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UNG-GC-2
2 mg experimental NRT product
|
Single-dose of new NRT product
Other Names:
|
Experimental: UNG-GC-4
4 mg experimental NRT product
|
Single-dose of new NRT product
Other Names:
|
Active Comparator: Nicorette® Gum-2
2 mg Nicorette® Gum
|
Single-dose of marketed nicotine gum
Other Names:
|
Active Comparator: Nicorette® Gum-4
4 mg Nicorette® Gum
|
Single-dose of marketed nicotine gum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic measurements
Time Frame: Baseline and during 10 hours after product administration
|
Pharmacokinetic measurements including:
|
Baseline and during 10 hours after product administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tmax
Time Frame: Baseline and during 10 hours after product administration
|
The time of occurrence of Cmax following product administration
|
Baseline and during 10 hours after product administration
|
Lamda z
Time Frame: Baseline and during 10 hours after product administration
|
The terminal nicotine elimination rate constant (λz)
|
Baseline and during 10 hours after product administration
|
Released amount of nicotine
Time Frame: After 30 minutes of chewing
|
The amount of nicotine released from gums during 30 minutes' chewing.
|
After 30 minutes of chewing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
June 28, 2010
First Submitted That Met QC Criteria
June 28, 2010
First Posted (Estimate)
June 29, 2010
Study Record Updates
Last Update Posted (Estimate)
July 10, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- NICTDP1075
- 2009-010633-44 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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