Comparing Two Torasemide 10 mg Tablet Formulations for Bioavailability in Healthy Adults Aged 18 to 55 Under Fasting Conditions

What this Trial Is About

This research evaluates the bioavailability, safety, and tolerability of two formulations of Torasemide 10 mg tablets in healthy adults under fasting conditions. It is a Phase I study comparing the test medication by Berlin-Chemie AG to Unat4 10 tablets by Viatris Healthcare GmbH to determine if the two formulations are bioequivalent. Participants receive a single 10 mg dose of either Torasemide 10 mg tablet by Berlin-Chemie AG or Unat4 10 tablets by Viatris Healthcare GmbH, orally with 240 mL of water while fasting. The study uses a randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design, where each participant receives both treatments in separate periods. During the study, researchers measure the maximum concentration C max and area under the curve AUC 0-last over 24 hours to assess bioavailability. Additional measures include other pharmacokinetic parameters such as T max, half-life, and elimination rate. Participants undergo clinical and laboratory assessments to confirm health status and monitor safety. The total participation time and follow-up duration span up to one year for secondary outcomes.

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