Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers
Status:
Completed
Trial end date:
2018-01-09
Target enrollment:
Participant gender:
Summary
This is a research study to verify the same effectiveness and safety profile for the test
products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products,
Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized
mode. This verification is done in a so-called bioequivalence study, which means that the
same amount of the same active substance (nicotine), in the same dosage form, for the same
route of administration, and meeting the same or comparable standards is performed.
During the study visits, blood samples will be drawn to measure the level of the substance in
the blood to verify that the two test products are comparable to the reference products.
Tolerability of the treatments will be evaluated based on reported and observed adverse
events.