A Phase 1 interventional study of Fed- 60mg ER Torsemide and Fasting- 60mg ER Torsemide in Food-drug Interaction, sponsored by Sarfez Pharmaceuticals, Inc.. Completed at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Sarfez Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
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.
Sarfez Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing
Drug: Fed- 60mg ER Torsemide
Adult healthy subjects will fast overnight (at least 10h) prior to dosing
Drug: Fasting- 60mg ER Torsemide
60mg ER Torsemide will be given after high fat, high-calorie meal
Also known as: High fat/high-calorie fed conditions
60mg ER Torsemide will be given after overnight fasting
Also known as: Fasting conditions
Peak torsemide plasma concentration
Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions
Time frame: 36 hours
Total torsemide plasma concentration
Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions
Time frame: 36 hours
Urinary torsemide excretion
torsemide will be measured in urine over 36 hours post-dose (microgram/min)
Time frame: 36 hours
Urinary sodium excretion
36-hour sodium excretion will be measure (mmol/min)
Time frame: 36 hours
Plan to share: No
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Sarfez Pharmaceuticals, Inc.