healthy people
Conditions
Interventions
1:8 sub. orally 50mg Chinfloxacin Hydrochloride and 2 sub. placebo
2:8 sub. orally 100mg Chinfloxacin Hydrochloride and 2 sub. placebo
3:8 sub. orally 200mg Chinfloxacin Hydrochloride and 2 sub. placebo
4:8 sub. orally 300mg Chinfloxacin Hydrochloride and 4 sub. placebo
5:8 sub. orally 400mg Chinfloxacin Hydrochloride and 4 sub. placebo
6:8 sub. orally 600mg Chinfloxacin Hydrochloride and 4 sub. placebo
7:6 sub. orally 800mg Chinfloxacin Hydrochloride and 4sub. placebo
Sponsors
First Hospital, Peking University, China
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese male and female subjects, age between 18 to 45 years old; 2. Weighing over 45Kg, body weight index within 19.0-24.0kg/m2; 3. Vital signs, body examination, laboratory examination and other related trial examination at normal range or no clinical significant abnormal results before study; 4. With normal standard 12-ECG recording; 5. Female subjects no sexual activity within 2 weeks, and urine pregnancy test negative; 6. Must agree to use adequate birth control measures as precaution against partner's pregnancy (eg, contraceptives, intrauterine device, or a barrier method with spermicide) for at least 6 months following study agent administration; 7. Agree not to use prescription, over-the-counter (OTC), herbal, traditional Chinese medicines, or any "natural" medications from 14 days before study agent administration until the completion of the study; 8. Signed and dated a written Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Usually smoking, addicted to drink, and drug abuser; 2. Have a history of drug allergy, especially to quinolinones; 3. Have fever disease before 3 days of screening; 4. History of nervous system disease, psychiatric disorders and epilepsy; 5. Habitual medication including Chinese herbal drugs; 6. Blood donation over 360ml within 3 months; 7. Heart rate 100/min; 8. Systolic blood pressure 140mmHg, diastolic blood pressure > 90mmHg or 450msec; 10. Have serology positive for antibodies to HIV-1 or HIV-2, hepatitis B virus (HBV), or hepatitis C virus (HCV) and syphilis at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine rutine;Biochemical indices of liver and renal function;blood coagulation and haemolysis;Blood rutine;EEG;ECG; | — |
Countries
China
Contacts
Public ContactYuan Lv
Outcome results
None listed