Clinical trial NCT01847443: Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Official title: A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: nicotine
nicotine replacement therapy
nicotine gum
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: AUC(0-t) of Nicotine 4 mg Test and Reference Product
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: Cmax of Nicotine 4 mg Test and Reference Product
timeFrame: Blood samples to be collected from baseline to 12 hours post-dose
Secondary outcomes:
measure: Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
measure: 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
timeFrame: Blood samples to be collected from baseline to 12 hours post dose
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion - BELFAST
state: Northern Ireland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Du D. A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects. Adv Ther. 2018 Aug;35(8):1169-1180. doi: 10.1007/s12325-018-0752-7. Epub 2018 Jul 19.