Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Marketed Nicotine Tablet; Drug: Nicotine Sublingual Tablet Mint (NSTM)

• Registration Number: NCT01238627
• Lead Sponsor: McNeil AB

Brief Summary

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

Detailed Description

The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and Body Mass Index (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 months preceding the first dose of study medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microtab-2	Marketed Nicotine Tablet	2 mg Nicotine tablet
Microtab-4	Marketed Nicotine Tablet	2 x 2 mg Nicotine tablet
Nicotine Sublingual Tablet Mint (NSTM)-2	Nicotine Sublingual Tablet Mint (NSTM)	Experimental 2 mg NSTM
NSTM-4	Nicotine Sublingual Tablet Mint (NSTM)	Experimental 4 mg Nicotine Sublingual Tablet Mint

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