The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under fasting conditions.
Healthy male and female individuals aged 18 to 55 years inclusive at the time of signing the ICF.
Body weight ≥50 kg and Body Mass Index (BMI) between ≥18.5 and <30.0 kg/m2.
A healthy individual as determined by the Investigator based on medical history and results of standard clinical, laboratory and instrumental methods of examination (individuals with not clinically significant [NCS] abnormalities are eligible for the study).
A non-smoker (for at least 3 months before screening), verified by the cotinine test at screening.
Known hypersensitivity or intolerance to torasemide, other sulfonylureas, or any other excipient of the IMPs.
History of renal failure with anuria.
History of hepatic precoma, coma.
History of hypotension.