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CompletedNCT01847443Updated Apr 11, 2014Results posted

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

A Phase 1 interventional study of Nicotine (2 mg) and Nicotine (4 mg) in Smoking Cessation, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-11.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • nicotine
  • nicotine replacement therapy
  • nicotine gum
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Test nicotine gum (2 mg)

    A single dose of Nicotine Mint Gum (2 mg) to be chewed.

    Drug: Nicotine (2 mg)

  • Experimental
    Test nicotine gum (4 mg)

    A single dose of Nicotine Mint Gum (4 mg) to be chewed.

    Drug: Nicotine (4 mg)

  • Active comparator
    Reference nicotine gum (2 mg)

    A single dose of reference nicotine gum (2 mg) to be chewed.

    Drug: Nicotine (2 mg)

  • Active comparator
    Reference nicotine gum (4 mg)

    A single dose of reference nicotine gum (4 mg) to be chewed.

    Drug: Nicotine (4 mg)

Interventions

  • DrugNicotine (2 mg)

    2 mg nicotine gum in two formulations

  • DrugNicotine (4 mg)

    4 mg nicotine gum in two formulations

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Results

Posted Apr 11, 2014

Participant flow

Potential participants were recruited at a single site in the UK.

Study Period 1
Participant flow — Study Period 1
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started21212121
Completed21202121
Not completed0100
Withdrew: Withdrawal by subject0100
Washout Period Before Study Period 2
Participant flow — Washout Period Before Study Period 2
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started21202121
Completed19192121
Not completed2100
Withdrew: Adverse event1100
Withdrew: Other reason1000
Study Period 2
Participant flow — Study Period 2
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started19192121
Completed19192121
Not completed0000
Washout Period Before Study Period 3
Participant flow — Washout Period Before Study Period 3
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started19192121
Completed18192121
Not completed1000
Withdrew: Other reason1000
Study Period 3
Participant flow — Study Period 3
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started18192121
Completed18192121
Not completed0000
Washout Period Before Study Period 4
Participant flow — Washout Period Before Study Period 4
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started18192121
Completed16192121
Not completed2000
Withdrew: Withdrawal by subject1000
Withdrew: Positive alcohol test1000
Study Period 4
Participant flow — Study Period 4
Milestone2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Started16192121
Completed16192121
Not completed0000

Outcome measures

PrimaryArea 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
Reported as:
Mean · hr*ng/mL
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
hr*ng/mLTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product11.49 ± 4.22410.24 ± 3.768
Statistical analysis
  • Test Nicotine Gum (2 mg) vs Reference Nicotine Gum (2 mg) · ANOVA · Ratio of geometric means: 1.107 · 90% CI 1.070 to 1.147
SecondaryTime 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
Reported as:
Median · hr
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
hrTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)Test Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products0.75 (0.5 to 1.0)0.75 (0.5 to 1.5)0.75 (0.5 to 1.5)0.75 (0.2 to 2.0)
SecondaryApparent 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
Reported as:
Median · hr
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
hrTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)Test Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products2.12 (1.4 to 3.4)2.03 (1.2 to 4.2)2.01 (1.3 to 4.1)2.02 (1.3 to 3.4)
SecondaryApparent 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
Reported as:
Median · 1/hr
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
1/hrTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)Test Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products0.33 (0.2 to 0.5)0.34 (0.2 to 0.6)0.34 (0.2 to 0.5)0.34 (0.2 to 0.5)
SecondaryArea 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
Reported as:
Mean · hr*ng/mL
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
hr*ng/mLTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)Test Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
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 Products12.56 ± 4.40911.20 ± 3.95524.60 ± 7.84522.64 ± 7.136
PrimaryAUC(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
Reported as:
Mean · hr*ng/mL
AUC(0-t) of Nicotine 4 mg Test and Reference Product
hr*ng/mLTest Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
AUC(0-t) of Nicotine 4 mg Test and Reference Product23.44 ± 7.59321.50 ± 6.874
Statistical analysis
  • Test Nicotine Gum (4 mg) vs Reference Nicotine Gum (4 mg) · ANOVA · Ratio of geometric means: 1.098 · 90% CI 1.061 to 1.137
PrimaryMaximum 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
Reported as:
Mean · ng/mL
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
ng/mLTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product3.93 ± 1.2323.72 ± 1.289
Statistical analysis
  • Test Nicotine Gum (2 mg) vs Reference Nicotine Gum (2 mg) · ANOVA · Ratio of geometric means: 1.044 · 90% CI 1.002 to 1.089
PrimaryCmax 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
Reported as:
Mean · ng/mL
Cmax of Nicotine 4 mg Test and Reference Product
ng/mLTest Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
Cmax of Nicotine 4 mg Test and Reference Product7.49 ± 1.7206.98 ± 1.777
Statistical analysis
  • Test Nicotine Gum (4 mg) vs Reference Nicotine Gum (4 mg) · ANOVA · Ratio of geometric means: 1.071 · 90% CI 1.028 to 1.116

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Nicotine Gum (2 mg)—0/82 (0%)11/82 (13.4%)
Reference Nicotine Gum (2 mg)—0/77 (0%)12/77 (15.6%)
Test Nicotine Gum (4 mg)—0/79 (0%)12/79 (15.2%)
Reference Nicotine Gum (4 mg)—0/81 (0%)11/81 (13.6%)
Most frequent other events
Showing 10 of 41
Most frequent other events
EventTest Nicotine Gum (2 mg)Reference Nicotine Gum (2 mg)Test Nicotine Gum (4 mg)Reference Nicotine Gum (4 mg)
HeadacheNervous system disorders2/824/775/791/81
NauseaGastrointestinal disorders0/822/771/791/81
Abdominal pain upperGastrointestinal disorders0/820/772/791/81
Catheter site related reactionGeneral disorders0/820/772/790/81
Abdominal painGastrointestinal disorders1/820/770/792/81
FatigueGeneral disorders2/820/770/791/81
TachycardiaCardiac disorders0/821/770/790/81
Chapped lipsGastrointestinal disorders0/821/770/790/81
Dry mouthGastrointestinal disorders0/821/770/790/81
ToothacheGastrointestinal disorders1/821/770/790/81

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Total Participants
Mean26.8 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)Total Participants
Female40
Male44
08

Study locations

1 site
  • Celerion - BELFAST
    Belfast, Northern Ireland BT9 6AD, United Kingdom
09

References and documents

Publications

  • 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. PubMed 30027479 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01847443
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 6, 2013
Start date
May 2013
Primary completion
Jun 2013
Completion
Jun 2013
Results posted
Apr 11, 2014
Last update
Apr 11, 2014

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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