JPRN-jRCT2071210016CompletedPhase 1
Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects
Huang Jinhong0 sites14 target enrollmentStarted: April 28, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 40age old (—)
- Sex
- Male
Inclusion Criteria
- •(1) Provided written informed consent
- •(2) Men aged 20 or older and younger than 40 years at the time of consent
- •(3) Weigh at least 50.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height (m)]2) ranging from 18.5 to < 25.0 kg/m2
- •(4) Vital signs 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) Pulse rate ranging from 40 to 99 beats/min
- •d) Body temperature (axilla) ranging from 35.0 to 37.0
- •(5) 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
Exclusion Criteria
- •(1) Accompanying diseases considered inappropriate for participation in this study including hepatic diseases, renal diseases, gastrointestinal diseases, cardiovascular diseases, hematologic diseases, respiratory diseases, immunologic or allergic diseases, neurological or psychiatric diseases, metabolic or endocrinological diseases, or malignant tumors, or a history of these diseases
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