drugset / Trial / NCT00796315
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children
NaSingle-groupOpen-label
Summary
The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to \< 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxylamine | Small molecule | 3.125 mg | — |
| Subject | Doxylamine | Small molecule | 12.5 mg | — |