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| Name | Class |
|---|---|
| Alachua Government Services, Inc. | INDUSTRY |
| Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam Injection | Experimental | Midazolam injection, 10 mg |
|
| Seizalamâ„¢ | Active Comparator | Seizalam, 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Combination Product | Midazolam Injection, 10mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with local injection site changes | 28 days | |
| number of participants with systemic changes in physical exam | 28 days | |
| number of participants with vital signs changes resulting in a serious adverse event | 28 days | |
| number of participants with ECG changes resulting in a serious adverse event | 28 days | |
| number of participants with laboratory changes resulting in a serious adverse event | 28 days | |
| time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection | 28 days | |
| The elimination rate constant (ke) will be estimated | 28 days | |
| The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability will be obtained by analysis of Cmax | 28 days | |
| Relative bioavailability will be obtained by analysis of AUC0-last | 28 days | |
| Relative bioavailability will be obtained by analysis of AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Research | Raleigh | North Carolina | 27612 | United States |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Seizalam |
| Drug |
Seizalam, 10 mg |
|
| 28 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |