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Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Not Applicable
Completed
Conditions
Tobacco Dependence
Interventions
Drug: 6 mg Experimental nicotine gum
Drug: 4 mg Nicotine Gum/
Drug: 2 mg Nicotine Gum
Registration Number
NCT01234792
Lead Sponsor
McNeil AB
Brief Summary

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed Description

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria
  • Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
  • 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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
NIC-66 mg Experimental nicotine gum6 mg Experimental nicotine gum
NIC-44 mg Nicotine Gum/4 mg Nicotine Gum
NIC-22 mg Nicotine Gum2 mg Nicotine Gum
Primary Outcome Measures
NameTimeMethod
Maximum Observed Plasma Concentration (Cmax)During 8 hours post-dose

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

Area Under the Curve (AUC)(0-t)During 8 hours post-dose

AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).

AUC(0-∞)8 hours post-dose

AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

McNeil AB Clinical Pharmacology R&D

🇸🇪

Lund, Sweden

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