Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
This study has been completed.
Sponsor:
McNeil AB
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01238640
First received: November 9, 2010
Last updated: July 6, 2012
Last verified: July 2012
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Results First Received: March 11, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Basic Science |
| Condition: |
Tobacco Dependence |
| Interventions: |
Drug: Code STD Drug: Code STE Drug: Nicorette Microtab |
Participant Flow
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 |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Overall Study | No text entered. |
Participant Flow: Overall Study
| Overall Study | |
|---|---|
| STARTED | 84 |
| COMPLETED | 84 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Overall Study | No text entered. |
Baseline Measures
| Overall Study | |
|---|---|
|
Number of Participants
[units: participants] |
84 |
|
Age
[units: years] Mean ± Standard Deviation |
32.2 ± 9.32 |
|
Gender
[units: participants] |
|
| Female | 35 |
| Male | 49 |
|
Region of Enrollment
[units: participants] |
|
| Sweden | 84 |
Outcome Measures
| 1. Primary: | Maximum Observed Plasma Concentration (Cmax) [ Time Frame: During 10 hours post-dose ] |
| 2. Primary: | Area Under the Curve [AUC(0-t)] [ Time Frame: During 10 hours post-dose ] |
| 3. Primary: | AUC(0-∞) [ Time Frame: 10 hours post-dose ] |
| 4. Secondary: | Product Dissolution Time [ Time Frame: During 10 hours post-dose ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhaue@its.jnj.com
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhaue@its.jnj.com
No publications provided
| Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ) |
| ClinicalTrials.gov Identifier: | NCT01238640 History of Changes |
| Other Study ID Numbers: | NICTDP1072, 2008-002788-15 |
| Study First Received: | November 9, 2010 |
| Results First Received: | March 11, 2011 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Sweden: Medical Products Agency |