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Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges

NCT03432273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-08-09

No results posted yet for this study

Summary

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

Conditions

  • Smoking Cessation

Interventions

DRUG

Nicotine lozenge

Nicotine mint lozenge, 2 mg

DRUG

Nicotine lozenge

NiQuitin mint lozenge, 2 mg

Sponsors & Collaborators

  • Fertin Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Yolandi Swart, Dr. · PAREXEL (South Africa)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • South Africa

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 NCT03432273 on ClinicalTrials.gov