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

• ClinicalTrials.gov Identifier: NCT01238640
• Recruitment Status: Completed
• First Posted: November 10, 2010
• Results First Posted: April 8, 2011
• Last Update Posted: July 13, 2012
• Sponsor: McNeil AB
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Tobacco Dependence	Drug: Code STD; Drug: Code STE; Drug: Nicorette Microtab	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers
• Study Start Date: August 2008
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Code STD; An experimental 2 mg nicotine product coded "STD"	Drug: Code STD; 2 mg Single-dose of experimental nicotine product coded "STD"; Other Name: Not marketed
Experimental: Code STE; An experimental 2 mg nicotine product coded "STE"	Drug: Code STE; 2 mg Single-dose of experimental nicotine product coded "STE"; Other Name: Not marketed
Active Comparator: Nicorette Microtab; A comparative 2 mg marketed nicotine product called Nicorette Microtab	Drug: Nicorette Microtab; A comparative 2 mg Single-dose of marketed tablet; Other Name: Nicorette® Microtab

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Sweden

McNeil AB Clinical Pharmacology R&D

Lund, Sweden, SE-222 20

Sponsors and Collaborators

McNeil AB

Investigators

• Study Director: Elisabeth Kruse, PhD; McNeil AB

More Information

• Responsible Party: McNeil AB
• ClinicalTrials.gov Identifier: NCT01238640
• Other Study ID Numbers: NICTDP1072; 2008-002788-15 ( EudraCT Number )
• First Posted: November 10, 2010
• Results First Posted: April 8, 2011
• Last Update Posted: July 13, 2012
• Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):

Smoking Cessation; Nicotine

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action