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RECRUITING
NCT07201584
PHASE1

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

Sponsor: Berlin-Chemie AG Menarini Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-09-05

Completion Date

2026-04-01

Last Updated

2026-01-14

Healthy Volunteers

Yes

Interventions

DRUG

Torasemide tablet 10 mg

Tablets by Berlin-Chemie AG (Germany)

DRUG

Unat® 10 tablets (Torasemide 10 mg)

Tablets by Viatris Healthcare GmbH (Germany)

Locations (1)

LLP MedStartUp

Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan