Trial intelligence / Profile preview

PK and Safety of Kimyrsa vs Orbactiv in ABSSSI

NCT03873987Phase 1Completed

Sponsor
Melinta Therapeutics
Start
Jul 2019
Primary completion
Aug 2019
Modality
Peptides, Small Molecules
Countries
1
01

Overview

Phase 1, randomised, open-label trial of oritavancin in acute bacterial skin and skin structure infection (ABSSSI) (2 arms), sponsored by Melinta Therapeutics. Primary endpoints: Relative Exposure of AUC of the New Formulation to the Approved Formulation (Timeframe: 72 hours) and Relative Exposure of AUC of the New Formulation to the Approved Formulation (Timeframe: 168 hours (Day 8)). Started Jul 2019; status: completed.

02

Drugs

oritavancin
03

Conditions

acute bacterial skin and skin structure infection (ABSSSI)

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