Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01084603
First received: March 9, 2010
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: April 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: Oral Nicotine
Drug: NiQuitinTM Nicotine Lozenge
Drug: Nicorette® Nicotine Gum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Overall Study Full Safety Set

Participant Flow for 10 periods

Period 1:   Baseline
    Overall Study  
STARTED     45  
COMPLETED     43  
NOT COMPLETED     2  
Withdrawal by Subject                 2  

Period 2:   NiQuitinTM Lozenge
    Overall Study  
STARTED     43  
COMPLETED     42  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 3:   Washout Period 1
    Overall Study  
STARTED     42  
COMPLETED     42  
NOT COMPLETED     0  

Period 4:   Nicorette® Gum
    Overall Study  
STARTED     42  
COMPLETED     41  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 5:   Washout Period 2
    Overall Study  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     0  

Period 6:   Oral Nicotine 1
    Overall Study  
STARTED     41  
COMPLETED     40  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 7:   Washout Period 3
    Overall Study  
STARTED     40  
COMPLETED     40  
NOT COMPLETED     0  

Period 8:   Oral Nicotine 2
    Overall Study  
STARTED     40  
COMPLETED     40  
NOT COMPLETED     0  

Period 9:   Washout Period 4
    Overall Study  
STARTED     40  
COMPLETED     39  
NOT COMPLETED     1  
Adverse Event                 1  

Period 10:   Oral Nicotine 4
    Overall Study  
STARTED     39  
COMPLETED     39  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study Full Safety Set

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  45  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     45  
>=65 years     0  
Gender  
[units: participants]
 
Female     21  
Male     24  
Region of Enrollment  
[units: participants]
 
Sweden     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration   [ Time Frame: During 12 hours after start of administration ]

2.  Primary:   Bioavailability   [ Time Frame: 12 hours ]

3.  Secondary:   Nicotine Plasma Concentration   [ Time Frame: During 10 minutes after start of administration ]

4.  Secondary:   Time of Maximum Concentration   [ Time Frame: During 12 hours after start of administration ]

5.  Secondary:   Terminal Elimination Rate Constant   [ Time Frame: During 12 hours after start of administration ]

6.  Secondary:   Released Nicotine   [ Time Frame: After 30 minutes' chewing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joyce Hauze, Sr Specialist, Clinical Research Operations
Organization: J&J Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com


No publications provided


Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01084603     History of Changes
Other Study ID Numbers: NICTDP1065/A6431116, 2008-006280-36
Study First Received: March 9, 2010
Results First Received: April 16, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration