Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
Status:
Recruiting
Trial end date:
2024-08-23
Target enrollment:
Participant gender:
Summary
This study aims to compare the pharmacokinetics and pharmacodynamics of intravenous (IV) and
subcutaneous (SC) furosemide. The test formulation in this study is furosemide injection, 80
mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial
formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV
injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the
reference drug.
The objectives of this study are:
- To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics
of furosemide administered as SC injection via autoinjector compared with equivalent
dose of furosemide administered as two 40 mg IV injections, two hours apart.
- To describe the safety and tolerability of furosemide administered as SC injection via
an autoinjector.