Trials / Completed
CompletedNCT04679623
Study of Midazolam in Healthy Adults
Phase 1, Open-Label, Comparison Study to Evaluate the Safety and Pharmacokinetics of a Single Intramuscular Administration of 10 mg Midazolam Using an Auto-Injector vs Marketed Midazolam Vials in Healthy Adults.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Rafa Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Midazolam | Midazolam Injection, 10mg |
| DRUG | Seizalam | Seizalam, 10 mg |
Timeline
- Start date
- 2021-06-09
- Primary completion
- 2021-09-17
- Completion
- 2021-09-17
- First posted
- 2020-12-22
- Last updated
- 2022-03-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04679623. Inclusion in this directory is not an endorsement.