drugset / Trial / NCT02561442

Crossover Study to Compare the Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone Administration

NCT02561442

Phase 2/3 Completed 18 enrolled scPharmaceuticals, Inc.
RandomizedCrossoverOpen-labelBasic science

Summary

The proposed study aims to assess the time above MIC (4 mg/mL), and the pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone administered as a constant IV infusion over 0.5 hours. In addition, the study will compare the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2 g ceftriaxone administered subcutaneously

Timeline

Start
2015-10
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftriaxone Other / unclassified 1 g Intravenous
Subject Ceftriaxone Other / unclassified 2 g Intravenous

Indications

No indication recorded.