Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers|
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: During 10 hours post-dose ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Product Dissolution Time is the time from administration until the investigational products were completely dissolved.
|Study Start Date:||August 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.