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

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Code STD; Drug: Code STE; Drug: Nicorette Microtab

• Registration Number: NCT01238640
• Lead Sponsor: McNeil AB

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Results First Submitted: 2011-03-11
• Results First Submitted QC: 2011-03-11
• Results First Posted: 2011-04-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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
Code STD	Code STD	An experimental 2 mg nicotine product coded "STD"
Code STE	Code STE	An experimental 2 mg nicotine product coded "STE"
Nicorette Microtab	Nicorette Microtab	A comparative 2 mg marketed nicotine product called Nicorette Microtab

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	During 10 hours post-dose	Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
Area Under the Curve [AUC(0-t)]	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).
AUC(0-∞)	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 Outcome Measures

Name	Time	Method
Product Dissolution Time	During 10 hours post-dose	Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Trial Locations

Locations (1)

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