NCT03214874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

July 8, 2017

Last Update Submit

April 17, 2018

Conditions

Congestive Heart FailureChronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Urinary sodium excretion

    24 hour

  • Urine output

    24 hour

Study Arms (2)

Demadex 20mg Tablet

ACTIVE COMPARATOR

Demadex (IR Torsemide) 20mg tablet once daily is the reference listed drug (RLD) and is marketed for decades to treat edema in Chronic Congestive Heart Failure (CHF) and Chronic Kidney Disease (CKD) patients

Drug: Demadex 20mg Tablet

ER Torsemide 20mg Tablet

EXPERIMENTAL

ER Torsemide 20mg tablet once daily is is the new formulation that will release the active ingredient over an extended period

Drug: ER Torsemide 20mg Tablet

Interventions

Demadex 20mg TabletDRUG

Immediate Release (IR) Torsemide

Also known as: Torsemide
Demadex 20mg Tablet
ER Torsemide 20mg TabletDRUG

Extended Release Torsemide 20 mg tablet given once daily

Also known as: ER Torsemide
ER Torsemide 20mg Tablet

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female, non-smoker, weight 50 kg for male and 45 kg for female, clinically acceptable laboratory profiles with ECG and chest X-ray performed within 6 months

You may not qualify if:

  • participation in bioavailability/bioequivalence studies,
  • history of drug abuse or alcohol dependence,
  • history of allergies including drug allergies,
  • known hypersensitivity to Torsemide or related drugs,
  • presence of clinically significant disorder,
  • systolic blood pressure \<90 mm Hg or \> 140 mm Hg diastolic blood pressure,
  • history of incontinence,
  • positive urine drug screening etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.E.C. Consultants

Bangalore, India

Location

Related Publications (1)

  • 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.

    PMID: 11705426RESULT

MeSH Terms

Conditions

Heart FailureRenal Insufficiency, Chronic

Interventions

TorsemideTablets

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Christopher Wilcox, MD, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Fully Replicate double-crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 12, 2017

Study Start

June 19, 2017

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)