None
Conditions
Interventions
Low single-dose group:Sitafloxacin 50mg tablet p.o.
Middle single-dose group:Sitafloxacin 100mg tablet p.o.
High single-dose group:Sitafloxacin 200mg tablet p.o.
Multi-dose group:Sitafloxacin 100mg tablet BID p.o. for 7 days
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1)Healthy male or female; (2)Aged 20-45 years (including 20 and 45); (3)Body weight=50 kg, body mass index (BMI) [body weight (kg)/height2 (m2)] 19-24, including the lower and upper limits; (4)12-lead ECG shows no clinically significant abnormality; (5)Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) With a history of cardiovascular, liver, renal, gastrointestinal, psychiatric or nervous system disease; (2) With a history of drug allergy; (3) With epilepsy or other convulsive disorders; (4) Pregnant or lactating women, women of child bearing age who adopt no effective contraceptive measure, or women who plan to bear a child during the trial; (5) Positive for HIVAb, HBsAg, HCVAb or syphilis test; (6) Laboratory examination or physical examination abnormality which is considered as clinically significant by the investigator; (7) Sitting systolic pressure 140 mmHg; sitting diastolic pressure 90 mmHg; sitting pulse 99 bpm; (8) Can not quit alcohol or smoking during the hospitalization; (9) Screening examination shows positive result in drug abuse or alcohol test; (10) Previous nausea in blood donation or blood collection; (11) Donate blood or have blood collection as a subject in the past 3 months; (12) Have surgery within 1 month prior to enrollment; (13) Participate in another clinical drug trial within 1 month prior to enrollment, or plan to participate in another clinical drug trial during this trial; (14) Take drugs (including commercial drugs) within 14 days prior to enrollment; (15) Previously participate in a clinical trial of sitafloxacin; (16) Require selective surgery during the trial; (17) Investigators, affiliated study staff or their relatives; (18) Subjects not suitable to participate in this trial as evaluated by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK paremeters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoint; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital affiliated to Fudan University
Outcome results
None listed