Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 11, 2014
CompletedApril 11, 2014
January 1, 2014
1 month
May 2, 2013
March 6, 2014
March 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Blood samples to be collected from baseline to 12 hours post-dose
Secondary Outcomes (4)
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
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
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
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
Study Arms (4)
Test nicotine gum (2 mg)
EXPERIMENTALA single dose of Nicotine Mint Gum (2 mg) to be chewed.
Test nicotine gum (4 mg)
EXPERIMENTALA single dose of Nicotine Mint Gum (4 mg) to be chewed.
Reference nicotine gum (2 mg)
ACTIVE COMPARATORA single dose of reference nicotine gum (2 mg) to be chewed.
Reference nicotine gum (4 mg)
ACTIVE COMPARATORA single dose of reference nicotine gum (4 mg) to be chewed.
Interventions
2 mg nicotine gum in two formulations
4 mg nicotine gum in two formulations
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
Celerion - BELFAST
Belfast, Northern Ireland, BT9 6AD, United Kingdom
Related Publications (1)
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.
PMID: 30027479DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 6, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
April 11, 2014
Results First Posted
April 11, 2014
Record last verified: 2014-01