RecruitingPhase 1NCT07201584

A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:

A Comparative Bioavailability of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions: a Prospective, Open-label, Randomized, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study

Sponsor

Berlin-Chemie AG Menarini Group

Enrollment

26 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Adult Male and Female Volunteers

Summary

The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under fasting conditions.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Torasemide tablet 10 mg and a drug called Unat® 10 tablets (Torasemide 10 mg) for people with healthy adult male and female volunteers. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTorasemide tablet 10 mg

Tablets by Berlin-Chemie AG (Germany)

DRUGUnat® 10 tablets (Torasemide 10 mg)

Tablets by Viatris Healthcare GmbH (Germany)

Locations(1)

LLP MedStartUp

Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan

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NCT07201584

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