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

Description

To study comparative bioavailability (BA) of single dose of the FDC (24 mg ER Torsemide and 30 mg Spironolactone) tablet given with or without food in healthy adult subjects.

The total expected study duration is at least 11 days from the day of check-in for Period 1 to the end of Period 2.

There will be a washout period of at least 07 days will be maintained in between the periods.

Treatment will be as follows:

(A): Fixed dose combination (FDC) of 24 mg ER Torsemide + 30 mg Spironolactone tablet without food.

Dose: 1x (24 mg +30 mg) FDC tablet

Treatment (B):

FDC (24 mg ER Torsemide + 30 mg Spironolactone) tablet with food. Dose: 1x (24 mg +30 mg) FDC tablet

Route of Administration for both treatments: Oral