NCT03130179

A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.

A Single-dose, Two-period, Crossover, Randomized, Fasting, Open-label, Bioequivalence Study Between Nicorette Strongmint Lozenge 4 mg and Niquitin Minimint Lozenge 4 mg in Adult Healthy Smokers Motivated to Quit.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a research study to verify the same effectiveness and safety profile for the test product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint lozenge (reference product), 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 products are comparable. Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Detailed description

This is a single-dose, two-period crossover, randomized, fasting, open-label, bioequivalence study. 244 male and female volunteers with a smoking history of minimum 3 months and aged between 18 and 45 years, inclusive, and motivated to quit will be included. The treatment administration order will be randomized with an equal number of subjects in each treatment sequence. Single doses of 4 mg Nicorette Strongmint Lozenge (i.e. test product) and 4 mg NiQuitin® Minimint Lozenge (i.e. reference product) will be administered in a standardized mode, on two separate treatment visits. A washout period of minimum 48 hours will separate the treatment administrations. An abstinence period of 12 hours including an overnight stay at the clinic is required at both treatment occasions. Blood for pharmacokinetic analyses will be drawn pre-dose (i.e. within 5 minutes before drug administration) and at 10, 15, 20, 30, 40, 50, and 60 minutes, as well as 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours after start of drug administration. Thus, 17 samples will be collected per treatment visit. Subjects will be monitored to capture any adverse events that may occur.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicorette Strongmint lozenge 4 mg	A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.
DRUG	Niquitin MiniMint lozenge 4 mg	A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-06-19
• Completion: 2017-06-29
• First posted: 2017-04-26
• Last updated: 2018-07-27

Locations

1 site across 1 country: Russia