NCT04200261

Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects

Interventions

Type	Name	Description
DRUG	Banapenem	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
DRUG	sodium chloride	sodium chloride

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-09-30
• Completion: 2020-12-30
• First posted: 2019-12-16
• Last updated: 2019-12-16

Locations

1 site across 1 country: China