Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine Medicated Gum; Drug: 4 mg Nicotine Gum; Drug: 2 mg Nicotine Gum; Drug: 4 mg Nicotine Lozenge

• Registration Number: NCT01234896
• Lead Sponsor: McNeil AB

Brief Summary

Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Detailed Description

Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-11
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Completion: 2010-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 kilograms per square meter and a total body weight of at least 55.0 kilograms.
• 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

Group	Intervention	Description
Nicotine Gum 6	Nicotine Medicated Gum	6 mg Nicotine medicated gum
Nicotine Gum 4	4 mg Nicotine Gum	4 mg Nicotine Gum
Nicotine Gum 2	2 mg Nicotine Gum	2 mg Nicotine Gum
Nicotine Lozenge	4 mg Nicotine Lozenge	4 mg Nicotine Lozenge

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	12 hours post-dose	Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
Area Under the Curve (AUC)(0-t)	12 hours post-dose	AUC(0-t), which 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).
AUC (0-∞)	12 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

Name	Time	Method
AUC(10 min)	10 minutes post-dose	AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes

Trial Locations

Locations (1)

McNeil AB Clinical Pharmacology R&D; 🇸🇪 Lund, Sweden