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

Tobacco Dependence Clinical Trial

Official title:

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238640
• Other study ID #: NICTDP1072
• Secondary ID: 2008-002788-15
• Status: Completed
• Phase: N/A
• First received: November 9, 2010
• Last updated: July 6, 2012
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Code STD
2 mg Single-dose of experimental nicotine product coded "STD"
• Code STE
2 mg Single-dose of experimental nicotine product coded "STE"
• Nicorette Microtab
A comparative 2 mg Single-dose of marketed tablet

Locations

Country	Name	City	State
Sweden	McNeil AB Clinical Pharmacology R&D	Lund

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)	During 10 hours post-dose	No
Primary	Area Under the Curve [AUC(0-t)]	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).	During 10 hours post-dose	No
Primary	AUC(0-8)	AUC (0-8) 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-8).	10 hours post-dose	No
Secondary	Product Dissolution Time	Product Dissolution Time is the time from administration until the investigational products were completely dissolved.	During 10 hours post-dose	No