drugset / Trial / NCT02471690

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers

NCT02471690

Phase 1 Completed 56 enrolled The Medicines Company
RandomizedParallel-groupQuadruple-blindOther

Summary

The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin

Timeline

Start
2015-07
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oritavancin Other / unclassified 1200 mg Intravenous

Indications

No indication recorded.