Phase 1
N=84
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01847443 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product — 11.49; 10.24 hr*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nicotine (2 mg) (Drug); Nicotine (4 mg) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product |
11.49; 10.24 | — |
| PRIMARY AUC(0-t) of Nicotine 4 mg Test and Reference Product |
23.44; 21.50 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product |
3.93; 3.72 | — |
| PRIMARY Cmax of Nicotine 4 mg Test and Reference Product |
7.49; 6.98 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products |
0.75; 0.75; 0.75; 0.75 | — |
| SECONDARY Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products |
2.12; 2.03; 2.01; 2.02 | — |
| SECONDARY Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products |
0.33; 0.34; 0.34; 0.34 | — |
| SECONDARY 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 |
12.56; 11.20; 24.60; 22.64 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01847443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.