A Food Effect Study of 60mg ER Torsemide

Sarfez Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Food-drug Interaction

Treatments: Drug: Fasting- 60mg ER Torsemide; Drug: Fed- 60mg ER Torsemide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03215875

CLCD-061-17

Details and patient eligibility

About

This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers. The study will be conducted as a two-sequence to period crossover study to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER torsemide is a new strength and dosage form.

Full description

Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure unless dietary salt intake is severely restricted. Extended Release (ER) torsemide is being developed to address this drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet. Since 60mg ER torsemide is a new strength and dosage form, this study will test 60mg ER torsemide for a food effect in healthy volunteers who are either fasting or consuming a high-fat meal (fed). The primary endpoint of the study is full pharmacokinetics measurements after a single dose of 60mg ER torsemide. The secondary endpoints are 24h sodium excretion and total urinary excretion.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• participation in bioavailability/bioequivalence studies in past six months
• history of drug abuse or alcohol dependence
• history of allergies, known hypersensitivity to Torsemide and related drugs
• presence of clinically significant disorder
• suffer from high/low blood pressure (<90 and >140 mm Hg)
• positive urine drug screening, and
• history of incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Fed- 60mg ER Torsemide

Experimental group

Description:

Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing

Treatment:

Drug: Fed- 60mg ER Torsemide

Fasting- 60mg ER Torsemide

Experimental group

Description:

Adult healthy subjects will fast overnight (at least 10h) prior to dosing

Treatment:

Drug: Fasting- 60mg ER Torsemide