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

ABSTRACT:

Objective

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 current manufacturing process for alteplase was recently modified to meet increasing global demands. The aim of this randomized, open-label, adaptive two-stage design, two-way crossover study was to establish bioequivalence of alteplase derived from the two manufacturing processes (modified versus current).

Methods

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 =

SUBMITTER: Glund S 

PROVIDER: S-EPMC10338556 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature