Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01238640|
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : April 8, 2011
Last Update Posted : July 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Drug: Code STD Drug: Code STE Drug: Nicorette Microtab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Code STD
An experimental 2 mg nicotine product coded "STD"
Drug: Code STD
2 mg Single-dose of experimental nicotine product coded "STD"
Other Name: Not marketed
Experimental: Code STE
An experimental 2 mg nicotine product coded "STE"
Drug: Code STE
2 mg Single-dose of experimental nicotine product coded "STE"
Other Name: Not marketed
Active Comparator: Nicorette Microtab
A comparative 2 mg marketed nicotine product called Nicorette Microtab
Drug: Nicorette Microtab
A comparative 2 mg Single-dose of marketed tablet
Other Name: Nicorette® Microtab
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: During 10 hours post-dose ]Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
- Area Under the Curve [AUC(0-t)] [ Time Frame: During 10 hours post-dose ]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).
- AUC(0-∞) [ Time Frame: 10 hours post-dose ]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-∞).
- Product Dissolution Time [ Time Frame: During 10 hours post-dose ]Product Dissolution Time is the time from administration until the investigational products were completely dissolved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238640
|McNeil AB Clinical Pharmacology R&D|
|Lund, Sweden, SE-222 20|
|Study Director:||Elisabeth Kruse, PhD||McNeil AB|