Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Furosemide for administration · 1 trial · 1 indication
Statistical summaries with a graphical presentation will show mean and individual diuresis and natriuresis time profiles such as time to first void, volume of first void, diuresis and natriuresis measured at 60 minute intervals up to 480 minutes following furosemide injection solution for subcutaneous administration or oral tablets. The diuretic response will be compared between therapies using t-tests or Wilcoxon test.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours followed by Oral Furosemide tablets (80 mg) in second period. |
| Group 2 | EXPERIMENTAL | Oral Furosemide tablets (80 mg) followed by Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours in second period. |
| Name | Type | Description |
|---|---|---|
| Furosemide injection solution for subcutaneous administration (80 mg) | DRUG | - |
| Oral Furosemide tablets (80 mg) | DRUG | - |
Inclusion Criteria: * Written informed consent obtained before any assessment is performed * Male and female subjects ≥18 years of age, with body weight \<120 kg and body mass index (BMI) \<30 kg/m2 * Female subjects must be at least 2 years post-menopausal * Participant must have been on oral furo...
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