drugset / Trial / NCT03873987
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
RandomizedParallel-groupOpen-labelBasic science
Summary
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
Timeline
- Start
- 2019-07-16
- Primary completion
- 2019-08-27
- Completion
- 2019-09-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oritavancin | Other / unclassified | 1200 mg | Intravenous |
Indications
No indication recorded.