NCT07201584

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Berlin-Chemie AG Menarini Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this Phase I study, the test medication Torasemide 10 mg tablets (Berlin-Chemie AG) is compared to Unat® 10 tablets (Viatris Healthcare GmbH) in terms of bioequivalence of the tested formulations under fasting conditions

Conditions

• Healthy Adult Male and Female Volunteers

Interventions

Type	Name	Description
DRUG	Torasemide tablet 10 mg	Tablets by Berlin-Chemie AG (Germany)
DRUG	Unat® 10 tablets (Torasemide 10 mg)	Tablets by Viatris Healthcare GmbH (Germany)

Timeline

• Start date: 2025-09-05
• Primary completion: 2025-12-30
• Completion: 2026-04-01
• First posted: 2025-10-01
• Last updated: 2026-01-14

Locations

1 site across 1 country: Kazakhstan