A Food Effect Study of 60mg ER Torsemide

Sarfez Pharmaceuticals, Inc.28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food-drug Interaction

Interventions

Fed- 60mg ER TorsemideDRUG

60mg ER Torsemide will be given after high fat, high-calorie meal

Fasting- 60mg ER TorsemideDRUG

60mg ER Torsemide will be given after overnight fasting

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

I.E.C. Consultants

Bangalore, India

Outcomes

Primary Outcomes

Peak torsemide plasma concentration

Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions

Time frame: 36 hours

Total torsemide plasma concentration

Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions

Time frame: 36 hours

Secondary Outcomes

Urinary torsemide excretion

torsemide will be measured in urine over 36 hours post-dose (microgram/min)

Time frame: 36 hours

Urinary sodium excretion

36-hour sodium excretion will be measure (mmol/min)

Time frame: 36 hours

Data from ClinicalTrials.gov

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