Tokyo, Sept. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062769) titled 'A Study to Investigate Nicotine Pharmacokinetics Following Use of PA in Healthy Adults Who Smoke Combustible Cigarettes' on Sept. 11.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - JAPAN TOBACCO INC.

Condition: Condition - Smokers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this single-center, randomized, open-label, crossover study is to investigate nicotine pharmacokinetics following use of PA in healthy adults who smoke combustible cigarettes under confined conditions, using combustible cigarettes as comparators. Basic objectives2 - Others

Intervention: Interventions/Control_1 - [Non-menthol smokers] Use of non-menthol flavor cigarette (Day1) - Use of non-menthol flavor PA (Day2) Interventions/Control_2 - [Non-menthol smokers] Use of non-menthol flavor PA (Day1) - Use of non-menthol flavor cigarette (Day2)

Eligibility: Age-lower limit - 21 years-old

Gender - Male and Female Key inclusion criteria - -Individuals who have smoked commercial combustible cigarettes for 1 year or more and have a positive urine cotinine test at screening -Individuals who are judged by the investigator to be in good health on the basis of the results of clinical assessments performed by the start of the investigation period on Day1 -Individuals who are willing to participate in the study, understand the informed consent document, and provide written or electronic informed consent, etc. Key exclusion criteria - -Individuals who have regularly used any tobacco products other than commercial combustible cigarettes within 4 weeks prior to Day 1 -Females who are or may be pregnant, or who are lactating -Individuals who are employees of the tobacco industry or any other parties involved in the study, etc. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 12 Day Anticipated trial start date - 2026 Year 09 Month 24 Day Last follow-up date - 2026 Year 11 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071864

Disclaimer: Curated by HT Syndication.