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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
2 mg nicotine gum in two formulations
4 mg nicotine gum in two formulations
Celerion - BELFAST
Belfast, Northern Ireland, United Kingdom
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg Test and Reference Product
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
Cmax for 2 mg test was compared with 2 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Cmax of Nicotine 4 mg Test and Reference Product
Cmax for 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post-dose
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
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Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Time frame: Blood samples to be collected from baseline to 12 hours post dose