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Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)

NCT01959607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-01-16

Study results available
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Summary

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

Conditions

  • Smoking

Interventions

OTHER

THS 2.2

Single use of the Tobacco Heating System 2.2 (THS 2.2)

OTHER

CC

Single use of subject's own cigarette (CC)

OTHER

NRT Gum

Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Masayuki Sugimoto, MD PhD · Koganeibashi Sakura Clinic

  • Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
23 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-11-30
Completion
2014-04-30

Countries

  • Japan

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 NCT01959607 on ClinicalTrials.gov