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Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem inClinical Healthy Subjects

NCT03570970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-06-27

No results posted yet for this study

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 clinical study.

Conditions

  • Healthy Subject

Interventions

DRUG

Banapenem

Banapenem to be used anti-infection

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuan Lv, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-14
Primary Completion
2016-06-02
Completion
2016-06-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570970 on ClinicalTrials.gov