none Healthy adults
Conditions
Interventions
Smoking methoxyphenamine (50 mg) in a greenhouse of about 4.3 m3, similar to the capacity in a sedan-type car, for 5 minutes. Methoxyphenamine are heated and vaporized by electricity for one minute af
none
Active smoking, passive smoking
Sponsors
Morohoshi Hokuto
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: We determine persons who satisfy all of the following selection criteria as subjects. 1) Age : Those who are older than age 20 and under 50 when obtaining consent. 2) Gender : male 3) BMI : Between 18 and 30 4) Those who have the ability to consent and can observe the pre-examinations prescribed in this research implementation plan and report subjective symptoms etc. 5) Those who are judged to be helthy and eligible as subjects in this study group by reserach doctors in the pre-examinations stipulated in this research implementation plan.
Exclusion criteria
Exclusion criteria: We exclude persons who corresponding to any of the following criteria from this study. 1) Persons with a medical history that may affect the evaluation and safety of this study. For example, drug abuse-dependent, alcohol abuse-dependent, heart, liver, kidney, lung, eye and vascular disease etc. 2) Those who are taking medications (includes supplements and health supplements ) that may affect the evaluation and safety of this study. 3) Those with a history of drug and food allergies. 4) Current smokers 5) Those who cannot stop drinking alcohol during this study. 6) Within 3 months from other clinical trials. 7) Persons who has been judged unsuitable as subjects of this study by the research doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary concentrations of methoxyphenamine and o-desmethylmethoxyphenamine compared active and passive smoking, using urine samples collected as following: before drug administration as a control, 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-60 hr, 60-72 hr, 72-84 hr, 84-96 hr after drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary excretions of methoxyphenamine and o-desmethylmethoxyphenamine compared active and passive smoking, using the results of primary outcomes and total urine volumes (0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-60 hr, 60-72 hr, 72-84 hr, 84-96 hr after drug administration). All adverse events that occurred during this study. | — |
Contacts
Public ContactHokuto Morohoshi
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Outcome results
None listed