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

NCT01238640 | Completed Results

• 2 other identifiers: NICTDP10722008-002788-15
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Dependence

Keywords

Smoking Cessation; Nicotine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• AUC(0-∞)

  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-∞).

  10 hours post-dose

Secondary Outcomes (1)

• Product Dissolution Time

  During 10 hours post-dose

Study Arms (3)

Code STD

EXPERIMENTAL

An experimental 2 mg nicotine product coded "STD"

Drug: Code STD

Code STE

EXPERIMENTAL

An experimental 2 mg nicotine product coded "STE"

Drug: Code STE

Nicorette Microtab

ACTIVE COMPARATOR

A comparative 2 mg marketed nicotine product called Nicorette Microtab

Drug: Nicorette Microtab

Interventions

Code STD DRUG

2 mg Single-dose of experimental nicotine product coded "STD"

Also known as: Not marketed

Code STD

Code STE DRUG

2 mg Single-dose of experimental nicotine product coded "STE"

Also known as: Not marketed

Code STE

Nicorette Microtab DRUG

A comparative 2 mg Single-dose of marketed tablet

Also known as: Nicorette® Microtab

Nicorette Microtab

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

McNeil AB Clinical Pharmacology R&D

Lund, SE-222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

jhaue@its.jnj.com

928-277-0715

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 13, 2012
• Results First Posted: April 8, 2011

Record last verified: 2012-07

Locations

SE (1)