Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects

Phase 1 Completed 24 enrolled Sarfez Pharmaceuticals, Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

The study will evaluate the within-subject variability of 20mg ER torsemide as compared to 20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers, who are consuming a high-salt diet (300 mmol/day). The study will also evaluate the effects of ER torsemide and IR torsemide on 24h sodium excretion and total urinary excretion.

Timeline

Start: 2017-06-19
Primary completion: 2017-07-20
Completion: 2017-07-20

Outcome

Met primary endpoint

paper Compared with furosemide-treated patients, torsemide-treated patients were less likely to need readmission for heart failure (39 [32%] vs. 19 [17%], P <0.01) PMID 11705426 ↗

Publications

Results Murray MD, Deer MM, Ferguson JA, Dexter PR, Bennett SJ, Perkins SM, Smith FE, Lane KA, Adams LD, Tierney WM, Brater DC. Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure. Am J Med. 2001 Nov;111(7):513-20. doi: 10.1016/s0002-9343(01)00903-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Torsemide	Other / unclassified	20 mg	—