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.
Crossover
Torasemide tablet 10 mg
DrugTablets by Berlin-Chemie AG (Germany)
Unat® 10 tablets (Torasemide 10 mg)
DrugTablets by Viatris Healthcare GmbH (Germany)
C max
Maximum plasma concentration
AUC 0-last
Area under the curve from time 0 to the last quantifiable time point
AUC 0-Inf
Area under the curve from time 0 to infinity
T max
Time to maximum plasma concentration
C last
Last observed quantifiable concentration
T last
Time to last quantifiable concentration
Analysis of Adverse Events (AEs)
Number (%) of subjects with Adverse Events
Analysis of Adverse Events (AEs)
Number (%) of subjects with drug-related AEs
Analysis of Adverse Events (AEs)
Number (%) of subjects withrawn from the study due to drug-related AEs
Analysis of Adverse Events (AEs)
Number (%) of subjects with Serious Adverse Events (SAEs)
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