A Study in Healthy Men to Compare 2 Different Formulations of Alteplase

NCT04419493 ↗

Phase 1 Completed 30 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

To establish the bioequivalence of alteplase derived from two different manufacturing processes.

Timeline

Start: 2020-06-23
Primary completion: 2021-06-21
Completion: 2021-06-21

Outcome

Met primary endpoint

paper The geometric means ratio and the respective 92.83% confidence intervals (CIs) for all primary and secondary pharmacokinetic endpoints were well within the prespecified equivalence boundaries of 80-125%. PMID 37248330 ↗

registry Geometric Least Squares Mean ratio (%) 102.20 (92.83% CI 94.87 to 110.10) NCT04419493 ↗

registry Geometric Least Squares Mean ratio (%) 105.81 (92.83% CI 99.18 to 112.88) NCT04419493 ↗

Publications

Glund S, Hoefler J, Lang B, Cafiero S, Panova-Noeva M, Place C, Wolff M. Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study. Clin Pharmacokinet. 2023 Jul;62(7):1023-1030. doi: 10.1007/s40262-023-01253-3. Epub 2023 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alteplase	Protein / enzyme biologic	0.2 mg/kg	Intravenous
Background	Heparin	Other / unclassified	—	—

Indications

No indication recorded.