A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
NCT07201584 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2026-01-14
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.
Conditions
- Healthy Adult Male and Female Volunteers
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)
Sponsors & Collaborators
-
Berlin-Chemie AG Menarini Group
lead INDUSTRY
Principal Investigators
-
Guldana Abdullaeva, MD · LLP MedStartUp, Ili district, Otegen Batyr settlement, Industrial Zone 200A, Almaty region
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-05
- Primary Completion
- 2025-12-30
- Completion
- 2026-04-01
Countries
- Kazakhstan
Study Locations
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