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A Food Effect Study of 60mg ER Torsemide

NCT03215875 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Food-drug Interaction

Interventions

DRUG

Fed- 60mg ER Torsemide

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

DRUG

Fasting- 60mg ER Torsemide

60mg ER Torsemide will be given after overnight fasting

Sponsors & Collaborators

  • Sarfez Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Wilcox, MD, PhD · Sarfez Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215875 on ClinicalTrials.gov