A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers

A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers - A pharmacokinetics study for A-801

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002472

Enrollment

Registered

2010-07-31

Start date

2009-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokers

Interventions

Washout period =&gt

Step1: Use of A-801 =&gt

Step2: Use of a popular commercial tobacco product

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Subjects who sign the study-specific consent form 2. Subjects who are confirmed to be in good health through the screening process 3. Smokers 4. Subjects who do not plan to quit smoking over the study period (from screening to step 2) etc.

Exclusion criteria

Exclusion criteria: 1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco 2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation) etc.

Design outcomes

Primary

Measure	Time frame
To investigate the nicotine pharmacokinetics including exposure level during the use of A-801 in comparison with a popular commercial tobacco product	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026