A Food Effect Study of 60mg ER Torsemide

Food-drug Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215875
• Other study ID #: CLCD-061-17
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2017
• Last updated: April 17, 2018
• Start date: October 17, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Sarfez Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Food-drug Interaction

Intervention

Drug:
• Fed- 60mg ER Torsemide
60mg ER Torsemide will be given after high fat, high-calorie meal
• Fasting- 60mg ER Torsemide
60mg ER Torsemide will be given after overnight fasting

Locations

Country	Name	City	State
India	I.E.C. Consultants	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Sarfez Pharmaceuticals, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak torsemide plasma concentration	Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions	36 hours
Primary	Total torsemide plasma concentration	Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions	36 hours
Secondary	Urinary torsemide excretion	torsemide will be measured in urine over 36 hours post-dose (microgram/min)	36 hours
Secondary	Urinary sodium excretion	36-hour sodium excretion will be measure (mmol/min)	36 hours