drugset / Trial / NCT04897750
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants \>2-6 years and 9 paediatric participants \>6-17 years.
Timeline
- Start
- 2021-08-19
- Primary completion
- 2022-05-16
- Completion
- 2022-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.5 mg/kg | Intranasal |
| Subject | Sufentanil | Other / unclassified | 0.5 ug/kg | Intranasal |