Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
|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.
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|