Healthy Adult Subjects
Conditions
Sponsors
EA Pharma Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Main inclusion criteria - Japanese healthy male adults aged 20 or older to 55 and under, when consented. - BMI: 18.5 to under 25.0 kg/m2 - No clinical concerns in the examinations and physiological and clinical laboratory tests at screening. Subjects with laboratory values deviating from the center's standards that the investigator or a subinvestigator judged to be eligible to participate. - Subjects who could consented in writing
Exclusion criteria
Exclusion criteria: Main exclusion criteria - Subjects with past history of diseases which are likely to seriously affect absorption, distribution, metabolism, and excretion of the investigational product or surgical history of digestive or biliary tract - Subjects complicated by gastrointestinal disease - Subjects with past history of drug allergy - Smoking subjects or subjects who stopped smoking within 3 months - Subjects with past history of drug or alcohol dependence or present illness - Subjects positive for HBs antigen, anti-HCV antibody, and anti-HIV-1 and -2 antibody, or positive in the serologic test for syphilis - Subjects using other prescription drugs within 28 days or using OTC drugs or vitamins within 3 days before treatment with the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Subjective symptoms, Objective findings, Hematological tests, Blood biochemical tests , Urinalysis, Blood pressure/pulse rate, Body temperature, Body weight, ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics AJM300 and metabolites | — |
Countries
Japan
Outcome results
None listed