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drugset / Trial / NCT03215875

A Food Effect Study of 60mg ER Torsemide

NCT03215875 ↗

Phase 1 Completed 28 enrolled Sarfez Pharmaceuticals, Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-10-17
Primary completion
2018-03-31
Completion
2018-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Torsemide Other / unclassified 60 mg Oral

Indications

No indication recorded.