A Drug-Drug Interaction Study of TAS5315 with CYP3A inhibitor in Healthy Adult Subjects
- Conditions
- healthy adult males and females
- Registration Number
- JPRN-jRCT2071220117
- Lead Sponsor
- asermoaddeli Ali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
1) Aged 18 or older and younger than 40 years at the time of consent
2) Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
3) Blood pressure and body temperature obtained in screening tests within the following ranges
a Systolic blood pressure (in supine position), 90 to 139 mmHg
b Diastolic blood pressure (in supine position), 40 to 89 mmHg
c Body temperature ranging from 35.0 to 37.4
4) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests
1) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
2) Had any severe disease history that may recur during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method