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Completed

NCT Number: NCT01238640

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Completed

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McNeil AB Clinical Pharmacology R&D

Lund, SE-222 20, Sweden

About this study

The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
  • Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
  • A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion criteria

  • Pregnancy, lactation or intended pregnancy.
  • Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Treatment and study plan

Code STD

Drug

2 mg Single-dose of experimental nicotine product coded "STD"

Other names: Not marketed

Code STE

Drug

2 mg Single-dose of experimental nicotine product coded "STE"

Other names: Not marketed

Nicorette Microtab

Drug

A comparative 2 mg Single-dose of marketed tablet

Other names: Nicorette® Microtab

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: During 10 hours post-dose

    Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)

  2. Area Under the Curve [AUC(0-t)]

    Time frame: During 10 hours post-dose

    Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).

  3. AUC(0-∞)

    Time frame: 10 hours post-dose

    AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).

Secondary outcomes

  1. Product Dissolution Time

    Time frame: During 10 hours post-dose

    Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 10, 2010
Registry last updated
Jul 13, 2012

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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