A Food Effect Study of 60mg ER Torsemide

A Randomized, Balanced, Single Dose, Two-treatment (Fed vs. Fasting), Two-period, Two-sequence, Crossover Study to Evaluate the Effects of Food on the Bioavailability of 60 mg ER Torsemide Tablet in Healthy Human Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03215875

Enrollment

Registered

2017-07-12

Start date

2017-10-17

Completion date

2018-03-31

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food-drug Interaction

Brief summary

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.

Detailed 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.

Interventions

DRUGFed- 60mg ER Torsemide

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

DRUGFasting- 60mg ER Torsemide

60mg ER Torsemide will be given after overnight fasting

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

60mg ER Torsemide study in fed and fasting conditions

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak torsemide plasma concentration	36 hours	Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions
Total torsemide plasma concentration	36 hours	Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions

Secondary

Measure	Time frame	Description
Urinary torsemide excretion	36 hours	torsemide will be measured in urine over 36 hours post-dose (microgram/min)
Urinary sodium excretion	36 hours	36-hour sodium excretion will be measure (mmol/min)

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026