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

Alteplase is a recombinant tissue plasminogen activator used for thrombolytic treatment in several indications and is currently approved in Europe under the brand name Actilyse The two alteplase formulations (modified and current, 0.2 mg/kg body weight) were compared in healthy male volunteers after intravenous infusion over a period of 30 min. The trial was put on hold after treatment of 12 subjects (Part A) and restarted as Part B (n = 18) with design adaptations, including a heparin bolus. Pharmacokinetic parameters of alteplase were determined from plasma concentration-time profiles. The pharmacokinetic parameters tested (AUC The 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 registration number: NCT04419493, 2019-004932-40 (EudraCT Number).

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