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Comparison of Pharmacokinetic Profiles of 3 New Nicotine Gum Formulations With a Reference Gum

NCT02356913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-02-05

No results posted yet for this study

Summary

The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between three new nicotine gum formulations and a reference nicotine gum in healthy smokers.

Conditions

  • Smoking Cessation

Interventions

DRUG

Nicotine gum

Sponsors & Collaborators

  • Fertin Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Tejas Acharya, M.D. · Synchron Research Services Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

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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 NCT02356913 on ClinicalTrials.gov