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

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Code STD

Code STE

Nicorette Microtab

About this trial

This is an interventional basic science trial for Tobacco Dependence focused on measuring Smoking Cessation, Nicotine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

McNeil AB Clinical Pharmacology R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Code STD

Code STE

Nicorette Microtab

Arm Description

An experimental 2 mg nicotine product coded "STD"

An experimental 2 mg nicotine product coded "STE"

A comparative 2 mg marketed nicotine product called Nicorette Microtab

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

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)]

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-∞)

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

Product Dissolution Time

Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Full Information

NCT ID

NCT01238640

First Posted

November 9, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01238640

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Code STD

Arm Type

Experimental

Arm Description

An experimental 2 mg nicotine product coded "STD"

Arm Title

Code STE

Arm Type

Experimental

Arm Description

An experimental 2 mg nicotine product coded "STE"

Arm Title

Nicorette Microtab

Arm Type

Active Comparator

Arm Description

A comparative 2 mg marketed nicotine product called Nicorette Microtab

Intervention Type

Drug

Intervention Name(s)

Code STD

Other Intervention Name(s)

Not marketed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Code STE

Other Intervention Name(s)

Not marketed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nicorette Microtab

Other Intervention Name(s)

Nicorette® Microtab

Intervention Description

A comparative 2 mg Single-dose of marketed tablet

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)

Time Frame

During 10 hours post-dose

Title

Area Under the Curve [AUC(0-t)]

Description

Time Frame

During 10 hours post-dose

Title

AUC(0-∞)

Description

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-∞).

Time Frame

10 hours post-dose

Secondary Outcome Measure Information:

Title

Product Dissolution Time

Description

Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Time Frame

During 10 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Kruse, PhD

Organizational Affiliation

McNeil AB

Official's Role

Study Director

Facility Information:

Facility Name

McNeil AB Clinical Pharmacology R&D

City

Lund

ZIP/Postal Code

SE-222 20

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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