Hypertension
Conditions
Interventions
aliskiren and sitagliptin
aliskiren and placebo
Sponsors
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) aged 20-35. b) Male. c) healthy based on a physical examination and medical history. d) Can abide by ban on caffeine and alcohol during the study period. e) Body mass index over 18.5 and under 24.9 inclusive at the time of screening. f) The subject is able to understand and abide by the study protocol, and is willing to provide voluntary consent in writing. g) Tested negative for examination of hepatitis (including HBs antigen and HCV antibodies) h) Tested negative for HIV antibodies at the time of screening.
Exclusion criteria
Exclusion criteria: a) Had medical history of participation in other clinical trials or the clinical study accompanied by medicine medication within three months. b) 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). c) 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). d) 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. e) 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. f) Had a clinically serious illness within 30 days prior to study drug administration. g) Has used some sort of health food, or medical product within seven days prior to study drug administration or will use it during the study period. h) Has smoked tobacco, or ingested nicotine or alcohol within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking and drinking during the study period. i) Tested positive for a specific abused substance (including alcohol) in the urine drug test at the screening. j) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC(0-inf), Cmax, t1/2) of aliskiren | — |
Countries
Japan
Contacts
Public ContactTakashi Moritoyo
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Outcome results
None listed