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COMPLETED Phase 3

A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects

NCT07043634 · View on ClinicalTrials.gov ↗

Study Summary

This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.

Interventions

  • COMBINATION_PRODUCT FDC (24 mg ER torsemide and 30 mg Spironolactone) without food
  • COMBINATION_PRODUCT FDC (24 mg ER torsemide and 30 mg Spironolactone) with food

Study Locations (1)

Virginia

  • Sarfez Pharmaceuticals — Vienna

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-06-15
Est. Completion 2025-12-30
Phase Phase 3

Sponsor

Sarfez Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07043634

The ClinicalTrials.gov registry entry for NCT07043634 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarfez Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bioavailability Heathy Volunteers appearing as the primary indexed condition, and to 2 interventions — of which FDC (24 mg ER torsemide and 30 mg Spironolactone) without food is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07043634 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07043634 about?

NCT07043634 is a clinical study titled "A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects". This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.

What is the current status of trial NCT07043634?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2025-06-15. Estimated completion is 2025-12-30.

What conditions does trial NCT07043634 study?

This clinical trial studies the following conditions: Bioavailability Heathy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07043634?

The interventions under investigation include: FDC (24 mg ER torsemide and 30 mg Spironolactone) without food (COMBINATION_PRODUCT), FDC (24 mg ER torsemide and 30 mg Spironolactone) with food (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07043634?

This trial is sponsored by Sarfez Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07043634 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial