search
Back to results

Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nicotine
Sponsored by
McNeil AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Smoking Cessation, Nicotine pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and 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.

Sites / Locations

  • McNeil AB Clinical Pharmacology R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

UNG-GA

UNG-GB

Nicorette® Gum

Arm Description

New NRT product

New NRT product

Nicorette® Gum

Outcomes

Primary Outcome Measures

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∞)

Secondary Outcome Measures

tmax
The time of occurrence of Cmax following product administration
Lamda z
The terminal nicotine elimination rate constant (λz)
Released amount of nicotine
The amount of nicotine released from gums during 30 minutes' chewing.

Full Information

First Posted
June 28, 2010
Last Updated
July 6, 2012
Sponsor
McNeil AB
search

1. Study Identification

Unique Protocol Identification Number
NCT01152723
Brief Title
Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Official Title
Single-dose Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum. A Study in Healthy Smokers.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.
Detailed Description
The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 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. Treatment labels will be concealed from subjects and study personnel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Smoking Cessation, Nicotine pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UNG-GA
Arm Type
Experimental
Arm Description
New NRT product
Arm Title
UNG-GB
Arm Type
Experimental
Arm Description
New NRT product
Arm Title
Nicorette® Gum
Arm Type
Active Comparator
Arm Description
Nicorette® Gum
Intervention Type
Drug
Intervention Name(s)
Nicotine
Other Intervention Name(s)
Experimental NRT UNG-GA and UNG-GB, and Nicorette® Gum
Intervention Description
2 mg, Single Dose
Primary Outcome Measure Information:
Title
Pharmacokinetic measurements
Description
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∞)
Time Frame
Baseline and during 8 hours after product administration
Secondary Outcome Measure Information:
Title
tmax
Description
The time of occurrence of Cmax following product administration
Time Frame
During 8 hours after start of product administration
Title
Lamda z
Description
The terminal nicotine elimination rate constant (λz)
Time Frame
During 8 hours after start of product administration
Title
Released amount of nicotine
Description
The amount of nicotine released from gums during 30 minutes' chewing.
Time Frame
After 30 minutes of chewing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Kruse, PhD
Organizational Affiliation
McNeil AB
Official's Role
Study Director
Facility Information:
Facility Name
McNeil AB Clinical Pharmacology R&D
City
Lund
ZIP/Postal Code
SE-222 20
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum

We'll reach out to this number within 24 hrs