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Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

NCT ID: NCT01228617

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-10-31

Brief Summary

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This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Detailed Description

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This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1 Short, no buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

A2 Short, low buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

A3 Short, high buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

B1 Long, no buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

B2 Long, low buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

B3 Long, high buffer

Nicotine / not yet marketed

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

R = Nicotine Gum

Nicorette® Gum

Group Type ACTIVE_COMPARATOR

Nicotine Gum

Intervention Type DRUG

Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

Interventions

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Nicotine

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

Intervention Type DRUG

Nicotine Gum

Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

Intervention Type DRUG

Other Intervention Names

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Not yet marketed Nicorette®

Eligibility Criteria

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Inclusion Criteria

* Healthy smokers, 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

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Clinical Trial Unit, Clinical Research and Trial Centre

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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A6431114-NICTDP1063

Identifier Type: -

Identifier Source: org_study_id