Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study

ConclusionsThe results show that alteplase exposure was virtually identical for the formulations tested, and statistical evaluation demonstrated bioequivalence of the formulations. Both formulations of alteplase were well tolerated by the subjects at the single intravenous doses in the trial.Trial RegistrationTrial registration number: NCT04419493, 2019-004932-40 (EudraCT Number).
Source: Clinical Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research