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A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults

NCT04755348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-03-30

No results posted yet for this study

Summary

This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).

Conditions

  • Tobacco Use
  • Tobacco Smoking
  • Cigarette Smoking

Interventions

OTHER

Product A

A 4mg nicotine pouch product

OTHER

Product B

A 4mg nicotine pouch product

OTHER

Product C

A 2mg nicotine lozenge product

OTHER

Product D

A 2mg nicotine lozenge product

OTHER

Product E

A 2mg nicotine lozenge product

OTHER

Product F

A 2mg nicotine lozenge product

Sponsors & Collaborators

  • British American Tobacco (Investments) Limited

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-03-20
Completion
2021-03-25

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 NCT04755348 on ClinicalTrials.gov