JPRN-UMIN000011279Completed未知
Independent study: Researching drug-drug interaction bitween etizolam and itraconazole - Independent clinical study (University of Tokyo)
P-One Clinic, Keikokai Medical Corp0 sites16 target enrollmentStarted: July 26, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 35years-old (—)
- Sex
- Male
Inclusion Criteria
- Not provided
Exclusion Criteria
- •a) Has hypotension (blood pressure of less than 100 mmHg during systole), hypertension (blood pressure of 140 mmHg or higher during systole) or diabetes (HbA1c NGSP 6.5% or higher). b) Has donated or lost over 200 ml (1 unit) of blood within four weeks prior to study drug administration or 400 ml (2 units) within 3 months, or is anemic (less than Hb 12 g/dl). c) Has a serious neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, digestive tract (including digestive tract disorders thought to impact trial drug absorption), respiratory, or metabolic disease in their medical history or as a concomitant condition. d) A clinically serious abnormality has been found by the principal investigator or one of the subinvestigators in the clinical test values, ECG or physical examination. e) Had a clinically serious illness within 30 days prior to study drug administration. f) Has used some sort of health food, grapefruit (including food containing it), or medical product within seven days prior to study drug administration or will use it during the study period. g) Has smoked tobacco or ingested nicotine within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period. h) Cannot abide by the ban on caffeine and alcohol during the study period. i) Tested positive for a specific abused substance in the urine drug test at the screening. j) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens. 15) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.
Investigators
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