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Completed

NCT Number: NCT01536704

Nicotine Lozenge Bioequivalence Study

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion NEBRASKA

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
  • Body Mass Index within the range 19-27 kilograms/meters^2

Exclusion criteria

  • Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Treatment and study plan

Nicotine (2 mg)

Drug

2 mg nicotine lozenge in two formulations

Nicotine (4 mg)

Drug

4 mg nicotine lozenge in two formulations

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    AUC(0-t) was evaluated using the trapezoid rule.

  2. Maximum Observed Plasma Concentration [Cmaximum (Max)]

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    Cmax was depicted from plasma concentration of nicotine.

Secondary outcomes

  1. AUC [0-infinity (Inf)]

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    AUC (0-inf) was evaluated using the trapezoid rule.

  2. Time to Reach Maximum Plasma Nicotine Concentration (Tmax)

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    Tmax was time at which Cmax of nicotine was reached.

  3. Apparent Elimination Half-life of Nicotine T(1/2)

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    T(1/2) was calculated using plasma time-concentration values.

  4. Elimination Rate Constant for Plasma Nicotine: K (el)

    Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

    Kel was calculated with the help of plasma time concentration values.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 22, 2012
Registry last updated
Apr 26, 2013

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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