Pharmacokinetic study
Conditions
Interventions
First group:The reference preparation was given on an empty stomach
Second group:The test preparation was given on an empty stomach
Group A:The reference preparation was given after meals
Group B:The test preparation was given after meals
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy adult males and non-pregnant and non-lactating females aged between 18 and 55 (including 18 and 55 years old, but not excluding those over 55 years old during the trial period); 2.Male weight >=50kg, female weight >=45kg, body mass index (BMI) between 19 and 28kg/m^2, including boundary value; 3.Good health, history of cardiac, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases; 4.Before the test, the informed consent was signed, and the participants fully understood the test content, process and possible adverse reactions, and were able to communicate well with the researchers.
Exclusion criteria
Exclusion criteria: 1.Participated in other clinical trials within 90 days before the study, or plan to participate in other clinical trials during the study; 2.Subjects who had major surgery within 90 days before this trial, or plan to surgery 3 months after the trial; 3.Blood donation or massive blood loss (>300 mL, excluding female physiological period), or received blood transfusion within 90 days before this trial; 4.Subjects with gastrointestinal diseases such as esophageal reflux, stomach bleeding or peptic ulcer disease, heartburn occurs more than once a week, or any surgical procedure that may affect drug absorption (such as cholecystectomy) within 180 days; 5.Subjects with a history of specific allergies (such as asthma, urticaria, eczema, etc.), or allergy to two or more kinds of drugs, food and pollen, or allergy to any components of this preparation or cephalosporins, penicillin antibiotics; 6.Use of any medicines, including prescription, over-the-counter and/or alternative medicines (such as medicated diet, Chinese herbal medicine, hemostatic or health care products), hormonal contraception or vaccines within 28 days prior to the trial; 7.A history of psychotropic substance abuse; 8.Positive urine screening for substance abuse (THC, benzodiazepine, barbiturates, morphine, cocaine, methamphetamine); 9.Subjects who smoke more than 5 cigarettes per day 90 days before the study, subjects who drink frequently 28 days before the study, that is, drinking more than 7 units of alcohol(female)or 14 units of alcohol(males) per week (1 unit =150 mL of wine =360 mL of beer = 45 mL of alcohol); 10.Positive result of alcohol breathing test results; 11.Subjects with a positive skin allergy test for cephalosporins; 12.Patients with phenylketonuria; 13.Patients with liver and kidney dysfunction or impaired; 14.Body temperature (ear temperature) >=37.5?, respiratory abnormalities were obvious and the researchers considered that the patients were not suitable for the study, sitting systolic blood pressure >140mmHg or 90mmHg or 100 beats/min; 15.Positive for human immunodeficiency virus (HIV-AB), hepatitis B surface antigen (HBsAg), hepatitis C (anti-HCV) and syphilis antibody (TP); 16.Subjects who have special requirements for diet, and cannot comply with a unified diet during the test; 17.Subjects refuse to comply with the restriction of caffeine, alcohol, grapefruit (grapefruit juice) beverages and foods (including tea, chocolate, coffee, cola, etc.) 48 hours before taking medication; 18.Subjects with partners refuse to use effective contraception within 180 days from screening to completion of the study; 19.Female subjects have positive result of pregnancy test; 20.Dizziness of needles, dizziness or difficulty in venous blood collection; 21.There are obvious abnormalities in the physical examination and the investigator considers that they are not suitable for the study; 22.There are obvious abnormalities in electrocardiogram examination and the researcher considers that they are not suitable for the study; 23.There are obvious abnormalities in blood biochemistry, blood routine examination and urine routine examination and the researcher considers that they are not suitable for the test; 24.Subjects may not be able to complete the study for other reasons or may be deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameter;security index; | — |
Countries
China
Contacts
Public ContactJIn Feiyan
Dongyang Hengdian Hospital
Outcome results
None listed