NCT04921566

Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions

Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Torasemide Tab. 10mg (Pharmtechnology LLC,Belarus) and Toradiur® Tab. 10mg (MEDA Manufacturing Cologne, Germany) in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Torasemide tablet 10 mg	Torasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide.
DRUG	Toradiur® tablet 10 mg	Toradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide.

Timeline

• Start date: 2021-06-05
• Primary completion: 2021-06-20
• Completion: 2021-06-20
• First posted: 2021-06-10
• Last updated: 2023-06-29

Locations

1 site across 1 country: Russia