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Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

NCT01887847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-03-30

No results posted yet for this study

Summary

The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

Conditions

  • Nicotine Pharmacokinetic Study

Interventions

DRUG

Nicotine (Pharmaceutical Productions Inc.)

An investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.

DRUG

Nicotine (Pharmaceutical Productions Inc.)

A Commit® 2 mg nicotine lozenge (GlaxoSmith Kline)will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Pharmaceutical Productions Inc.

    lead INDUSTRY

Principal Investigators

  • Frank Vocci, Ph.D · Friends Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887847 on ClinicalTrials.gov