Conditions: Smoking Cessation
Keywords: nicotine nicotine replacement therapy nicotine gum
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 84
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Detailed description:

Arms:
arm 1: A single dose of Nicotine Mint Gum (2 mg) to be chewed. arm 2: A single dose of Nicotine Mint Gum (4 mg) to be chewed. arm 3: A single dose of reference nicotine gum (2 mg) to be chewed. arm 4: A single dose of reference nicotine gum (4 mg) to be chewed.

Interventions: intervention 1: Nicotine (2 mg) intervention 2: Nicotine (4 mg)
Intervention descriptions: intervention 1: 2 mg nicotine gum in two formulations intervention 2: 4 mg nicotine gum in two formulations

Protocol document: