Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

NCT01084603 | Completed Results

• 2 other identifiers: NICTDP1065/A64311162008-006280-36
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Conditions

Tobacco Dependence

Keywords

Smoking Cessation; Nicotine pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration

  Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

  During 12 hours after start of administration

• Bioavailability

  A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).

  12 hours

Secondary Outcomes (4)

• Nicotine Plasma Concentration

  During 10 minutes after start of administration

• Time of Maximum Concentration

  During 12 hours after start of administration

• Terminal Elimination Rate Constant

  During 12 hours after start of administration

• Released Nicotine

  After 30 minutes' chewing

Study Arms (5)

Oral Nicotine 1

EXPERIMENTAL

One oral administration of 1 mg nicotine

Drug: Oral Nicotine

Oral Nicotine 2

EXPERIMENTAL

Two oral administrations of 1 mg nicotine

Drug: Oral Nicotine

Oral Nicotine 4

EXPERIMENTAL

Four oral administrations of 1 mg nicotine

Drug: Oral Nicotine

NiQuitinTM Nicotine Lozenge 4 mg

ACTIVE COMPARATOR

One 4 mg marketed nicotine lozenge

Drug: NiQuitinTM Nicotine Lozenge

Nicorette® Gum 4 mg

ACTIVE COMPARATOR

One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

Drug: Nicorette® Nicotine Gum

Interventions

Oral Nicotine DRUG

A new l mg oral nicotine product

Also known as: Experimental nicotine 1 mg

Oral Nicotine 1; Oral Nicotine 2; Oral Nicotine 4

NiQuitinTM Nicotine Lozenge DRUG

A marketed 4 mg Nicotine lozenge

Also known as: NiQuitinTM lozenge

NiQuitinTM Nicotine Lozenge 4 mg

Nicorette® Nicotine Gum DRUG

A marketed 4 mg Nicotine Gum

Also known as: Nicorette® gum

Nicorette® Gum 4 mg

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 months preceding the first dose of study medication.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Clinical Pharmacology

Lund, 222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

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

jhauze@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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 13, 2012
• Results First Posted: July 8, 2010

Record last verified: 2012-07

Locations

SE (1)