Healthy Subjects
Conditions
Interventions
Normal population:According to the random distribution table, subjects were dosed with moxifloxacin (400 mg), Chinfloxacin Hydrochloride (400 mg, 600 mg) and placebo orally
Sponsors
First Hospital, Peking University, China
Eligibility
Sex/Gender
All
Age
19 Years to 43 Years
Inclusion criteria
Inclusion criteria: (1) Healthy Chinese male and female subjects, aged 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) No history of drug allergy, no history of neurological and mental illness, no history of epilepsy, no history of heart disease,no history of photosensitive reaction of Quinolone drugs, no history of tendonitis; (8) 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; (9) Signed and dated a written Informed Consent Form.
Exclusion criteria
Exclusion criteria: (1) Usually smoking, addicted to drink, and drug abuser; (2) History of organ damage drugs within 3 months; (3) History of drug allergy, especially to quinolinones, including photosensitivity reaction and allergic dermatitis; (4) Female subjects had sexual activity within 2 weeks, and urine pregnancy test positive; (5) Have fever disease before 3 days of screening; (6) History of nervous system disease, psychiatric disorders and epilepsy; (7) Habitual medication including Chinese herbal drugs; (8) History of drugs which may influence the trail, including antibacterial, non-steroidal anti-inflammatory drugs, antacids drugs which contain Aluminum or Magnesium, diuretics, anticoagulant, central nervous system inhibitors, and drugs might influence cardiac repolarization; (9) History of clinical trail within 3 months; (10) Blood donation over 360ml within 3 months; (11) Heart rate 100/min; (12) Systolic blood pressure 140mmHg, diastolic blood pressure > 90mmHg or 450msec, or the risk of TdP (including family ECG QT prolongation syndrome, heart failure, heart rhythm disorders, hypokalemia, and so on); (14) Patients were treated with extended QTc interval drugs; (15) History of tendonitis; (16) Have serology positive for antibodies to HIV-1 or HIV-2, hepatitis B virus (HBV), or hepatitis C virus (HCV) and syphilis at screening; (17) The other inappropriate factor which judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Plasma pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Urine rutine;Blood rutine;Blood biochemical; | — |
Countries
China
Contacts
Public ContactYuan Lv
Institute of Clinical Pharmacology, First Hospital, Peking University, China
Outcome results
None listed