| Trial ID: | L0626 |
| Source ID: | NCT03214874
|
| Associated Drug: |
Demadex 20mg Tablet
|
| Title: |
Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Congestive Heart Failure|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Demadex 20mg Tablet|DRUG: ER Torsemide 20mg Tablet
|
| Outcome Measures: |
Primary: Peak plasma concentration, Peak tosremide plasma concentration (Cmax) (ng/ml), 24 hour|Total plasma concentration, Area under the plasma concentration versus time curve (AUC) (hr/ng/ml), 24 hour|Urinary excretion, Torsemide excretion in urine (microgram/min) over 24h post dose, 24 hour | Secondary: Urinary sodium excretion, 24h sodium (mmol/min), 24 hour|Urine output, 24h total urinary output (l/day), 24 hour
|
| Sponsor/Collaborators: |
Sponsor: Sarfez Pharmaceuticals, Inc.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-19
|
| Completion Date: |
2017-07-20
|
| Results First Posted: |
|
| Last Update Posted: |
2018-04-18
|
| Locations: |
I.E.C. Consultants, Bangalore, India
|
| URL: |
https://clinicaltrials.gov/show/NCT03214874
|
