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CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

NCT04751461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-06-24

No results posted yet for this study

Summary

This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

P0213420, a 1.8% nicotine ENDS product

OTHER

Product B

P0213520, a 1.8% nicotine ENDS product

OTHER

Product C

P0211220, a 1.8% nicotine ENDS product

OTHER

Product D

P0211820, a 1.8% nicotine ENDS product

OTHER

Product E

P0213417, a 2.4% nicotine ENDS product

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Jason Hong, MD · RAIS

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
2021-02-23
Primary Completion
2021-04-20
Completion
2021-04-20

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 NCT04751461 on ClinicalTrials.gov