antimicrobials
Conditions
Interventions
T-R Group:T-R
R-T Group:R-T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are fully informed about the purpose, the characteristics, methods, and possible adverse reactions of the study, and are willing to participate in the study, and sign informed consent document before study; 2. 18~65 years of age (both inclusive); 3. Healthy man or woman; 4. Body mass index (BMI, weight [kg]/height2 [m]2) between 19.0 and 28.0 kg/m2 (both inclusive); body weight of male subjects is not less than 50 kg, body weight of female subjects is not less than 45 kg; 5. Subjects with no chronic disease or serious illness history of cardiovascular, hepatic, renal, respiratory, blood and lymph, endocrine, immune, mental, neurological, gastrointestinal, etc., disease; 6. Subjects (including male subjects) have no fertility plan, no sperm or egg donation plan and are willing to take effective contraception during study and for 6 months after receiving the last dose of study drug (Specific contraceptive measures in appendix 2); 7. Subjects are able to communicate well with investigator and to understand and adhere to the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to Moxifloxacin Hydrochloride and its excipient or other quinolones drug; other allergens (such as allergic to two or more drugs, food or pollen); 2. Subjects with dysphagia or gastrointestinal disease which will interfere drug absorption; 3. Subjects with major illness or underwent surgery within past 3 months prior to screening, or planned surgery during study, or have received any surgery may affect drug absorption, distribution, metabolism, excretion; 4. Known history of organic cardiopathy, heart failure, myocardial infarction, stenocardia, inexplicable arrhythmia, torsades de pointes (TDP), QT prolongation syndrome or QT prolongation symptom with family history (genetic evidences or sudden death in proximity of blood due to heart disease); 5. Subjects with abnormal ECG and CS by the investigators judgment, including but not limited to: a QTc interval >450 ms, QRS >110 ms or PR >200 ms; 6. Hypokalemia; 7. Subjects with difficulty in blood sampling, such as subjects with intolerance to direct venipuncture and have the history of acupuncture syncope and halo of blood; 8. Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before screening, or positive urine drug screening; 9. Participation in other drug clinical study less than 3 months prior to screening; 10. Subjects who have donated blood or have blood loss more than 200 mL, or subjects who received blood transfusions or use blood products, within 3 months prior to screening; 11. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding; 12. Usually use of hormonal medication (including oral contraceptives) within 3 months prior to screening; 13. Use of prescription medication, over the-counter products, herbal medicine and vitamins within 28 days before first dosing; 14. Receive any vaccine within 4 weeks prior to screening; 15. Smoking within 3 months (>5 cigarettes per day) before screening, or cannot abstain from any tobacco products during the study; 16. History of significant alcohol abuse within 3 months of screening or any indication of the regular use of more than 14 units of alcohol per week (1 Unit = 360 mL of beer or 45 mL liquor alcohol content of 40% or 150 mL of wine) or taking the product containing alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each period; or positive breath alcohol test; 17. Used to excessive (at least 8 cups per day, 1 cup=250 mL) drinking tea, coffee, or caffeine-containing beverages. Ingesting caffeine- or xanthine-containing products (e.g. coffee, tea, cola drinks, chocolate) for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each period; 18. Consumption of food or drinks known to induce or inhibit hepatic drug metabolism(i.e. pitaya, mango, grapefruit, lime, carambola or its products food or drink) within 72 hours before dosing and throughout the study; 19. Subjects with intolerance or a rare hereditary galactose intolerance to lactose, Lapp lactase deficiency or poor glucose-galactose absorption, such as diarrhea after drinking milk; 20. Subjects who cannot comply with standard meals with special dietary requirements; 21. Positive screening test for any one or more: human immunodeficiency virus (HIV) antibody, serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and treponema pallidum an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed