pilot study of micro dose
Conditions
Interventions
Trial Group :0.7mg Azilsartan Trimethylethanolamine single-dose
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, 12-lead ECG, clinical laboratory tests; 2. Age 18 to 40 years; 3. BMI 19-24 kg/m2(include 19 and 24),weight>=50 kg; 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria
Exclusion criteria: 1. Any finding of the medical examination deviating from normal and of clinical relevance; 2. Any evidence of a clinically relevant concomitant disease (Gastrointestinal, hepatic, renal,respiratory, cardiovascular, metabolic, immunological or hormonal disorders); 3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders; 4. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients); 5. Participation in another trial with an investigational drug within three months prior to administration or during the trial; 6. Smoker, Alcohol abuse or Drug abuse; 7. Blood donation (within three months prior to administration or during the trial); 8. Excessive physical activities (within one week prior to administration or during the trial); 9. Any laboratory value outside the reference range that is of clinical relevance; 10. A marked baseline prolongation of QT/QTc interval; 11. planning to become pregnant during the six month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure;Pulse;ECG; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Outcome results
None listed