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

NCT03214874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Congestive Heart Failure
  • Chronic Kidney Diseases

Interventions

DRUG

Demadex 20mg Tablet

Immediate Release (IR) Torsemide

DRUG

ER Torsemide 20mg Tablet

Extended Release Torsemide 20 mg tablet given once daily

Sponsors & Collaborators

  • Sarfez Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Wilcox, MD, PhD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2017-07-20
Completion
2017-07-20
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214874 on ClinicalTrials.gov