Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

NCT01227720 | Completed

• 1 other identifier: NICTDP1076
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Conditions

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration

  The maximum observed nicotine concentration in plasma (Cmax)

  during 12 hours after product administration

• Area under the Curve

  The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

  after 12 hours

Secondary Outcomes (3)

• Time of Maximum Concentration

  during 12 hours after start of product administration

• Terminal Elimination Rate Constant

  during 12 hours after start of product administration

• Oral Dissolution Time

  from administration until completely dissolved

Study Arms (6)

A NSL2L

EXPERIMENTAL

Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg

Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg

B Lozenge

ACTIVE COMPARATOR

Marketed Nicotine Lozenge 2 mg

Drug: Marketed Nicotine Lozenge

C NSL4M

EXPERIMENTAL

Experimental NRT (M) 4 mg

Drug: Experimental Nicotine Replacement Therapy (NRT)

D Lozenge

ACTIVE COMPARATOR

Marketed Nicotine Lozenge 4 mg

Drug: Marketed Nicotine Lozenge

E NSL4L

EXPERIMENTAL

Experimental NRT (L) 4 mg

Drug: Experimental Nicotine Replacement Therapy (NRT)

F NSL4H

EXPERIMENTAL

Experimental NRT (H) 4 mg

Drug: Experimental Nicotine Replacement Therapy (NRT)

Interventions

Experimental Nicotine Replacement Therapy (NRT) 2 mg DRUG

2 mg Single-dose of new NRT product (NSL2L)

Also known as: Not yet marketed

A NSL2L

Experimental Nicotine Replacement Therapy (NRT) DRUG

4 mg Single-dose of new NRT product

Also known as: Not yet marketed

C NSL4M; E NSL4L; F NSL4H

Marketed Nicotine Lozenge DRUG

2 mg Single-dose of marketed lozenge

Also known as: NiQuitin™ lozenge

B Lozenge

Eligibility Criteria

• Age: 19 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 (2)

Lund University Hospital Clinical Trial Unit

Lund, SE-221 85, Sweden

Location

McNeil AB Clinical Pharmacology R&D

Lund, SE-222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

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: October 22, 2010
• First Posted: October 25, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (2)