Regidor, P.-A.
Richter, W. H.
Koytchev, R.
Kirkov, V.
Colli, E.
Funding for this research was provided by:
Insud Pharma
Article History
Received: 20 October 2021
Accepted: 2 September 2022
First Online: 19 September 2022
Declarations
:
: We performed the study in accordance with Good Clinical Practice (GCP), local requirements and the Declaration of Helsinki. The Bulgarian Drug Agency and the local ethics committee at MHAT Tokuda Hospital (Sofia, Bulgaria) approved the study, and all subjects gave written informed consent.
: Not applicable.
: A written informed consent was obtained from all participants that were enrolled in the clinical trial.
: All authors have completed the Unified Competing Interest form. W. Richter, R. Koytchev are employed by Cooperative Clinical Drug Research and Development AG, Hoppegarten, Germany. V. Kirkov is employed at the Sector for Bioequivalence Trials at MHAT Tokuda Hospital Sofia AD, Bulgaria. E. Colli and P.-A. Regidor are employees of Exeltis Healthcare. There are no other financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.