Health
Conditions
Brief summary
The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers
Interventions
DRUGAzilsartan Trimethylethanolamine
DRUGPlacebo
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females * Aged from 18 years to 45 years * Body mass index (BMI) 19 to 25kg/m2
Exclusion criteria
* Has a known sensitivity to angiotensin II receptor blocker（ARB） * With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor * Has known or suspected history of alcoholism or drug abuse or misuse * With a history of laboratory results that show the presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV) * Pregnant,lactating，menstrual * Vegetarian * Postural hypotension * Systolic blood pressure\<100mmHg，or\>130mmHg;and/or diastolic blood pressure\<70mmHg,or\>90mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis | Pre-dose to 72 hours post-dosee | — |
| Number of participants with adverse reactions | Pre-dose to 72 hours post-dose | The trial shoud be terminated ，if more than a third of participants had grade 2 or more than 2 adverse reactions based on Common Terminology Criteria for Adverse Events(CTCAE) Version 4.02 |
Countries
China
Contacts
Primary ContactJie Hou, Associate Chief Physician
Outcome results
None listed