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

• Status: Completed
• Trial end date: 2017-07-20
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sarfez Pharmaceuticals, Inc.
• Treatments: Torsemide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.