hypertension
Conditions
Interventions
Different doses:Single-dose: 10mg, 20mg, 15mg, 20mg
Multiple-dose: 10 or 20 mg for 7 consecutive days
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Men and women (half and half)were eligible for entry into the study if they were between the ages of 18 and 45 years; 2. Body Mass Index of19–26 kg/m2, for man ,the weight must over 50kg, and women over 45kg; 3. To ensure a healthysubject population, subjects underwent screening, which included a detailed medical history, physical examination, including vital sign measurement, 12-lead electrocardiogram (ECG), and clinical laboratory tests; 4. subjects must signed informed consent.
Exclusion criteria
Exclusion criteria: 1. any significant clinical or laboratory abnormality; 2. personal history of hypersensitivity (especially to quinolone) including photosensitivity reaction; 3. tendonitis; 4. use of any drugs that could have affected cardiac repolarization within two weeks, such as anti-arrhythmic drugs, fluoroquinolone, and macrolide antibiotics; 5. heart rate 90 BPM; 6. systolic blood pressure 140 mmHg, diastolic blood pressure > 95 mmHg; 7. personal history of cardiac, nervous, ocular or endocrine disease; 8. HIV- or HBsAg-positive; 9. had donated blood within a month of study initiation, or intended to donate blood within a month after the study was concluded; 10. evidence of drug or alcohol abuse, or cigarette use; 11. participation in another clinical trial within three months of study enrollment; 12. prescription or over-the-counter medicines were taken within three weeks of study enrollment; 13. women who were nursing or attempting to conceive, or were who menstruating; and 14. QTc > 450 ms or QRS interval > 120 ms; 15. K+ < 3.6 mmol/l; 16. anyone who considered that they could not complete the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;QT interphase; | — |
Countries
China
Contacts
Public ContactWang Rui
Chinese PLA General Hospital
Outcome results
None listed