NCT02561442

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

A Single-Dose, Randomized, Three-way, Partially Blinded Crossover Study to Compare the Pharmacokinetics and Bioavailability of Ceftriaxone Administered as a 1 Gram Intravenous Infusion, a 1 Gram Subcutaneous Infusion and a 2 Gram Subcutaneous Infusion in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: scPharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Pharmacokinetics in Healthy Adults

Interventions

Type	Name	Description
DRUG	ceftriaxone

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-28
• Last updated: 2017-04-25

Regulatory

• FDA-regulated drug study