drugset / Trial / NCT04679623
Study of Midazolam in Healthy Adults
Phase 1
Completed
40 enrolled
Rafa Laboratories
Alachua Government Services, Inc. · collabJoint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.
Timeline
- Start
- 2021-06-09
- Primary completion
- 2021-09-17
- Completion
- 2021-09-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 10 mg | Intramuscular |
| Comparator | Seizalam | Unknown | 10 mg | — |
Indications
No indication recorded.