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INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone (INFUSE-Ceftriaxone) Study: A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYLENEX Recombinant) and Intravenously in Human Volunteers (INFUSE-Cftrx)
The objectives of this study are: * to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; * and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
Details
| Lead sponsor | Baxter Healthcare Corporation |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2007-06 |
| Completion | 2007-09 |
Conditions
- Healthy
Interventions
- SC HYLENEX and Ceftriaxone
- SC Placebo and Ceftriaxone
- IV Ceftriaxone
Primary outcomes
- AUC0-t — Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method) - AUC0-inf — from the start of ceftriaxone administration to infinity
Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)