Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Furosemide Injection, USP, Furosemide, USP, Furosemide Injection Solution (SCP-101)
Furosemide · 2 trials · 2 indications
The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
Assessment of pain will be conducted upon placement of the subcutaneous (SC) needle, upon activation of SC infusion and periodically during the infusion and post-infusion completion for up to 8 hours after the start of the infusion using a standardized 11 point pain scale. Score will range from 0 to 10, where zero is equivalent to no pain and 10 is equivalent to the worst possible pain.
| Arm | Type | Description |
|---|---|---|
| Furosemide Injection Solution, USP | ACTIVE_COMPARATOR | Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) |
| Furosemide Injection Solution (SCP-101) | EXPERIMENTAL | 80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment) |
| Cohort One | EXPERIMENTAL | A bi-phasic delivery over 5 hours |
| Cohort 2a | EXPERIMENTAL | Continuous infusion over 2 hours |
| Cohort 2b | EXPERIMENTAL | Bi-phasic delivery over 2 hours |
| Cohort 3 | EXPERIMENTAL | Continuous infusion over 1 hour. |
| Cohort 4 | EXPERIMENTAL | Continuous infusion over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Furosemide Injection Solution (SCP-101) | DRUG | - |
| Furosemide Injection Solution, USP | DRUG | - |
| Furosemide 80 mg (8 mg/mL) | DRUG | Furoscix will be administered as a subcutaneous infusion. |
Inclusion Criteria: * An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. * Male and female subjects \> 18 years of age * History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for hea...