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OpenTrials
Completed

NCT Number: NCT01847443

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - BELFAST

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine (2 mg)

Drug

2 mg nicotine gum in two formulations

Nicotine (4 mg)

Drug

4 mg nicotine gum in two formulations

Primary outcomes

  1. Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product

    Time frame: 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

  2. AUC(0-t) of Nicotine 4 mg Test and Reference Product

    Time frame: 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

  3. Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product

    Time frame: Blood samples to be collected from baseline to 12 hours post dose

    Cmax for 2 mg test was compared with 2 mg reference gum

  4. Cmax of Nicotine 4 mg Test and Reference Product

    Time frame: Blood samples to be collected from baseline to 12 hours post-dose

    Cmax for 4 mg test was compared with 4 mg reference gum

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

    Time frame: 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

  2. Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products

    Time frame: 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

  3. Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products

    Time frame: 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

  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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 6, 2013
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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