Infection caused by sensitive pathogens
Conditions
Interventions
After meal Second Group:RT
Fasting First Group:TR
Fasting Second Group:RT
After meal First Group:TR
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Subjects willing to provide written informed consent and fully understand the study content, study procedures and potential adverse event; 2) Subjects willing to follow the protocol requirements and finish the study; 3) Subjects(partners included) willing to have no pregnancy plan from screening to the next 6 months after the last dosing and take effective birth control measures listed in the appendix 5; 4) Female and Male subjects aged between 18 to 50 years (both inclusive); 5) Male subjects weighing not less than 50 kg, female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 18-28 (including the boundary value); 6) Subjects having normal or no clinical significant physical examination and vital signs.
Exclusion criteria
Exclusion criteria: 1) Daily smoking more than 5 cigarettes during past 3 months; 2) Hypersensitivity to investigate products and analogues of cephalosporin, penicillin, or other drugs or with allergic constitution(Hypersensitivity to several kind of drug or food); 3) History or presence of alcoholism(taking 14 units of alcohol per week: 1 unit is equal to 285 mL of beer, or 25 mL of spirits, or 100 ml of wine); 4) History of blood donating or blood loss within 3 months prior to screening(more than 450mL); 5) Difficulty in swallowing solids like tablets/capsules or history of gastrointestinal diseases affecting drug absorption; 6) Take any medication affecting the activity of hepatic enzyme during last 28 days prior to screening; 7) Take any prescribed medication,OTC medication,vitamins and herbal remedies during last 14 days prior to screening; 8) History of taking a special diet(including dragon fruits ,mangos,grapefruit ,etc) or strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion; 9) Subjects who have great changes on diet and exercise recently; 10) Consumption of investigational products, or participating in a clinical trial during last 3 months prior to dosing; 11) History or presence of significant easy bleeding, such as haemorrhoids, acute gastritis, gastric and duodenum ulcers; 12) Subjects cannot accept the standard diet (including 2 eggs, 1 piece of bread with bacon and butter, 1 box of potato chips, a cup of full milk); 13) Presence of significant ECG; 14) Female subjects in lactation period or have positive serum pregnancy test during the screening period or during the test; 15) Presence of significant laboratory examination or diseases (including but not limited to the gastrointestinal, renal, hepatic, neurological, hematic, endocrine, tumor, respiratory, immune, psychiatric or cardiovascular disease); 16) Positive screening test for any one or more: Hepatitis B, Hepatitis C,HIV,RPR; 17) Presence of illness or concomitant medication from screening to dosing; 18) Consumption of chocolate,caffeine/xanthine-containing products within 48 hours prior to dosing; 19) Consumption of alcoholic products within 48 hours prior to dosing; 20) Positive screening test for urine drug or history for drug abuse and consumption of narcotics past 5 years; 21) Other factors that investigator consider not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0~t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z;F;MRT; | — |
Countries
China
Contacts
Public ContactGuocheng Zhang
Jilin University First Hospital
Outcome results
None listed