drugset / Trial / NCT04294056
A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol
RandomizedCrossoverOpen-labelTreatment
Summary
This is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics (PD), pharmacokinetics (PK), and safety between ciprofol injectable emulsion and propofol injectable emulsion at different doses in healthy subjects.
Timeline
- Start
- 2020-05-26
- Primary completion
- 2020-06-22
- Completion
- 2020-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cipepofol | Small molecule | 0.4 mg/kg | — |
| Subject | Cipepofol | Small molecule | 0.6 mg/kg | — |
| Subject | Cipepofol | Small molecule | 0.8 mg/kg | — |
| Comparator | Propofol | Small molecule | 2 mg/kg | — |
| Comparator | Propofol | Small molecule | 3 mg/kg | — |
| Comparator | Propofol | Small molecule | 4 mg/kg | — |
Indications
No indication recorded.