A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (… (NCT07043634) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects
United States24 participantsStarted 2025-06-15
Plain-language summary
This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy human adult subjects within the age range of 18 to 45 years \[both inclusive\].
✓. Weight not less than 50 kg for male and 45 kg for female and BMI 18.50 to 29.99 kg/m2 \[both inclusive\].
✓. Willingness to provide written informed consent to participate in the study.
✓. Subjects should be non-smoker \[defined as someone who has stopped smoking for a year before the date of screening\] and should not be consuming tobacco containing products.
✓. Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray \[PA view\].
✓. Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
✓. Subject should be literate.
✓. Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and upto the study completion visit. Subjects must refrain from fathering a child in the next two weeks following the last study drug administration or have undergone vasectomy (vasectomy must have been done more than 6 months prior to first dosing). Contraceptive usage requirement will be conveyed during the inform consent process. Subjects will be advised to follow effective method of contraception until 2 weeks after the last dose is given.
Exclusion criteria
✕. History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal, psychiatric disease/disorder.
What they're measuring
1
Urine sample
Timeframe: 11 days
2
Blood Sample
Timeframe: Total duration is at least 11 days from day of check-in for Period 1 to end of Period 2.