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CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches

NCT05081154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-06-27

No results posted yet for this study

Summary

This study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Conditions

  • Smoking
  • Tobacco Use

Interventions

OTHER

Product A

P1012915, a nicotine pouch with 8 mg nicotine

OTHER

Product B

P1013018, a nicotine pouch with 10 mg nicotine

OTHER

Product C

P1013015, a nicotine pouch with 8 mg nicotine

OTHER

Product D

P1012815, a nicotine pouch with 8 mg nicotine

OTHER

Product E

P1013315, a nicotine pouch with 8 mg nicotine

OTHER

Product F

P1013115, a nicotine pouch with 8 mg nicotine

OTHER

Product G

P1013215, a nicotine pouch with 8 mg nicotine

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Milly Kanobe, PhD · 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
2021-10-20
Primary Completion
2021-11-24
Completion
2021-11-24

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 NCT05081154 on ClinicalTrials.gov