Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fursemide for administration · 1 trial · 1 indication
Maximum observed plasma concentration of Furosemide
Time to achieve maximum observed Furosemide plasma concentration
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
The percentage of AUC that is extrapolated beyond the last measurable concentration
Apparent plasma terminal-phase elimination rate constant
Terminal-phase half life
Systemic Volume of distribution, terminal phase for IV furosemide and Apparent Volume of distribution, terminal phase for SC furosemide
Systemic Clearance for IV furosemide and Apparent Systemic Clearance for SC furosemide
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period |
| Treatment Sequence 2 | EXPERIMENTAL | Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period. |
| Name | Type | Description |
|---|---|---|
| Fursemide Injection Solution for subcutaneous administration (80 mg) | DRUG | Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL) |
| Furosemide Injection, USP | DRUG | Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration. |
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, with body volume and weight \<130 kg and body mass index (BMI) \<38 kg/m2 * Females will be non-pregnant, non-l...
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