Glund, Stephan http://orcid.org/0000-0003-4582-3679
Hoefler, Josef
Lang, Benjamin
Cafiero, Stephen
Panova-Noeva, Marina
Place, Corina
Wolff, Michael
Clinical trials referenced in this document:
Documents that mention this clinical trial
Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study
https://doi.org/10.1007/s40262-023-01253-3
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Accepted: 12 April 2023
First Online: 30 May 2023
Declarations
:
: The study was supported and funded by Boehringer Ingelheim. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Medical writing support was provided by Shivani Singh of Meditech Media, a medical communications agency contracted and funded by Boehringer Ingelheim.
: SG, BL, SC, MPN, CP, and MW are employees of Boehringer Ingelheim. JH is employed by Staburo, contracted by Boehringer Ingelheim.
: To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to clinical study data pertinent to the development of the publication. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data when it becomes available on ExternalRef removed, and earliest after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete, and other criteria are met. Please visit ExternalRef removed for further information.
: The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). All authors approved the final version for submission. Study conceptualization and methodology: SG, CP, BL, and MW. Measurement and bioanalysis of pharmacokinetic concentration data: CP and SC. Calculation of pharmacokinetic parameters and data interpretation: SG. Bioanalysis of pharmacodynamic data: MW and MPN. Statistical analyses: JH and BL.
: Not applicable.
: All participants provided signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
: Not applicable.
: The trial was conducted and reported in accordance with the Declaration of Helsinki, the International Council for Harmonization Good Clinical Practice guidelines, and local regulations. Prior to the start of the trial, the subject information leaflet, the informed consent form, and other locally required documents were reviewed by the Independent Ethics Committee (IEC) of the participating center. The applicable IEC (Landesarztkammer Baden-Württemberg, Stuttgart, Germany) and medical regulatory authority (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM, Bonn, Germany) gave a favorable opinion and granted approval before the trial commenced at the investigational site.