drugset / Trial / NCT00494468
Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children
Phase 1/2
Completed
63 enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sanofi-Synthelabo · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter trial to evaluate the single-dose safety, tolerability and pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances stratified by age and dose.
Timeline
- Start
- 2002-10
- Primary completion
- —
- Completion
- 2004-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zolpidem | Small molecule | — | — |