Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
- Registration Number
- NCT01847443
- Lead Sponsor
- GlaxoSmithKline
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- BMI within the range of 19 to 30 kilograms/meters^2
- Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up
- Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
- Treatment with known hepatic enzyme altering agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test nicotine gum (4 mg) Nicotine (4 mg) A single dose of Nicotine Mint Gum (4 mg) to be chewed. Reference nicotine gum (4 mg) Nicotine (4 mg) A single dose of reference nicotine gum (4 mg) to be chewed. Test nicotine gum (2 mg) Nicotine (2 mg) A single dose of Nicotine Mint Gum (2 mg) to be chewed. Reference nicotine gum (2 mg) Nicotine (2 mg) A single dose of reference nicotine gum (2 mg) to be chewed.
- Primary Outcome Measures
Name Time Method AUC(0-t) of Nicotine 4 mg Test and Reference Product Blood samples to be collected from baseline to 12 hours post dose AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Cmax of Nicotine 4 mg Test and Reference Product Blood samples to be collected from baseline to 12 hours post-dose Cmax for 4 mg test was compared with 4 mg reference gum
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product Blood samples to be collected from baseline to 12 hours post dose Cmax for 2 mg test was compared with 2 mg reference gum
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product Blood samples to be collected from baseline to 12 hours post dose AUC(0-t) for 2 mg test was compared with 2 mg reference gum
- Secondary Outcome Measures
Name Time Method Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products Blood samples to be collected from baseline to 12 hours post dose Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products Blood samples to be collected from baseline to 12 hours post dose T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products Blood samples to be collected from baseline to 12 hours post dose Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
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 Blood samples to be collected from baseline to 12 hours post dose AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Trial Locations
- Locations (1)
Celerion - BELFAST
🇬🇧Belfast, Northern Ireland, United Kingdom