Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 12:56 PM
Study NCT ID:
NCT07043634
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Sarfez Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open Label, Randomized, Two-period, Two-sequence, Balanced, Single Dose Crossover Study to Evaluate the Effect of Food on the Bioavailability of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Human Subjects
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: