A Food Effect Study of 60mg ER Torsemide

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sarfez Pharmaceuticals, Inc.
• Treatments: Torsemide

Criteria

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