Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
Status and phase
Unknown
Phase 1
Conditions
Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
Treatments
Drug: Banapenem
Drug: sodium chloride
Details and patient eligibility
About
To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ/Ⅲclinical study.
Enrollment
20 estimated patients
Sex
All
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 1、 Male or female healthy subjects, aged 18~45(including 18 and 45 years); 2、Body weight ≥ 50 kg and body mass index 19.0~24.0 kg/m2; 3、Prior to the test, physical examination, blood routine, urine routine, liver and kidney functions, and related examinations normal, or mild abnormalities in indicators while without clinical significance as indicated by the investigator ; 4、Normal or mild abnormalities without clinical significance in the standard 12-lead ECG; 5、 Signing informed consent form.
Exclusion criteria
- 1、Having a serious systemic disease, infectious disease or mental disorder; 2、Regular smoking, alcohol abuse, and drug abuse ; 3、Use of drugs known damage to an organ within three months; 4、History of specific allergies, or history of drug allergy, especially those allergic to lactams and excipients of test drug; 5、Febrile illnesses within three days before the screening; 6、Patients with mental illness or psychotic disorder in the past; 7、Past mental and nervous system diseases (epilepsy, stroke, cerebrovascular disorder, etc.), gastrointestinal disorder (such as stomach ulcers, gastritis, etc.) or disorder of other systems (such as cardiovascular, respiratory, hematological, or endocrine system, etc.) diseases or medical history; 8、Habitually taking any medication, including traditional Chinese medicine; 9、Having taken any medication that may affect test results within two weeks before the screening, such as antibiotics, NSAIDs, aluminum- or magnesium-containing antacids, diuretics, anticoagulants, central nervous system depressants, and any drug that may affect the drug absorption; 10、Having participated in other investigational drug trial in the preceding three months; 11、Blood donation for 360 ml or more within three months before the screening; 12、Heart rate < 50 bpm or > 100 bpm; 13、Systolic blood pressure<90mmHg or ≥ 140mmHg, diastolic blood pressure ≥ 90 mmHg or <60mmHg ; 14、Women who are pregnant or breastfeeding, or who may be pregnant without adopting acceptable contraception, or who have a positive result in serum pregnancy test; 15、Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months; 16、HBsAg, HCV antibody, HIV antibody, and Treponema pallidum antibody positive; 17、Urine drug-of-abuse testing positive; 18、Any other factor that makes the subject not suitable for the trial as indicated by the investigator.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
20 participants in 2 patient groups, including a placebo group
Banapenem
Experimental group
Description:
2000 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 3000 mg group is then performed
Treatment:
Drug: Banapenem
placebo
Placebo Comparator group
Description:
sodium chloride injection Once daily for 7 days
Treatment:
Drug: sodium chloride
Trial contacts and locations
1
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Central trial contact
yuan lv, Doctor
Data sourced from clinicaltrials.gov
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