drugset / Trial / NCT01026636
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
Phase 1
Completed
64 enrolled
Basilea Pharmaceutica
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
NaSingle-groupOpen-labelBasic science
Summary
This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.
Timeline
- Start
- 2007-08
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftobiprole | Small molecule | 7 mg/kg | — |
| Subject | Ceftobiprole | Small molecule | 10 mg/kg | — |
| Subject | Ceftobiprole | Small molecule | 15 mg/kg | — |