Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT07043634
Brief 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.
Detailed 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
Study:
NCT07043634
Study Brief:
Protocol Section:
NCT07043634