High blood pressure
Conditions
Interventions
Healthy male subjects:trandolapril
Sponsors
The first hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1.Healthy male between 18 and 40 years of age, body weight = 50kg, the age difference between the subjects should not be more than 10 years old; 2.Body Mass Index (BMI) between 19-24kg/m2;3.No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening; 4.No birth plan within 3 months after completed the study;5. Ability to understand and provide written informed consent and voluntary consent to participate in the study;6.Ability to complete the study in compliance with the protocol;
Exclusion criteria
Exclusion criteria: 1. A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neurological disease); 2. A clinically significant ECG abnormality; 3. A positive hepatitis screen including hepatitis B surface antigen (HBsAg) and hepatitis C/HIV antibody; 4. Long-term smoking history (have smoked in 30 days before the study medication) 5. A history of hypersensitivity to trandolapril; 6. Has a history of drug and/or alcohol abuse; 7. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication; 8. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication; 9. Use of -pril drug ,such as captopril or enalaprilat, within 30 days prior to receiving study drug. 10. Use of any prescription drug therapy within 14 days prior to receiving study drug; 11. Use of any Vitamins or herbal products within 14 days prior to receiving study drug; 12. Consumption of alcohol within 24 hours prior to receive study drug; 13. Consumption of any grapefruit or grapefruit-containing juices within 7 days prior to receiving study drug; 14. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 15. Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving study drug; 16. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption; 17. Recent major changes in diet or exercise habits; 18. In the stage of screening or before using research medicine, acute disease occurred; 19. Have active peptic ulcer or bleeding, and always had recurrent ulcer or bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure, heart rat; | — |
Countries
China
Contacts
Public ContactXiaojiao Li
The first hospital of Jilin University
Outcome results
None listed