Radicioni, Milko http://orcid.org/0000-0002-3940-8375
Caverzasio, Carol
Rovati, Stefano
Giori, Andrea Maria
Cupone, Irma
Marra, Fabio
Mautone, Giuseppe
Clinical trials referenced in this document:
Documents that mention this clinical trial
Comparative Bioavailability Study of a New Vitamin D3 Orodispersible Film Versus a Marketed Oral Solution in Healthy Volunteers
https://doi.org/10.1007/s40261-021-01113-7
Funding for this research was provided by:
IBSA Institut Biochimique S.A., Pambio-Noranco, Switzerland
Article History
Accepted: 5 December 2021
First Online: 16 January 2022
Declarations
:
: This study was financially supported by IBSA Institut Biochimique S.A., Pambio-Noranco, Switzerland. IBSA is the owner and manufacturer of the vitamin D3 orally disintegrating film product.
: S.R., C.C, G.M are employees of IBSA Institut Biochimique S.A., Switzerland. I.C, F.M, A.M.G are employees of IBSA Farmaceutici Italia, Italy. M.R is an employee from CROSS Research S.A., Switzerland. The authors report no other conflicts of interest in this work.
: The study protocol and all relevant documentation were reviewed and approved by an independent Ethics Committee, the Comitato Etico Cantonale, Canton Ticino, Switzerland; Appendix 16.1.3; Project ID: 2019-00932/CE3479, reference number 2019DR1093). The study was conducted in compliance with the tenets of the Declaration of Helsinki and according to the International Conference on Harmonisation Good Clinical Practice guidelines (GCP) and the Swiss “Ordinance on Clinical Trials in Human Research 810.305 (OSRUm)”.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: De-identified subject data that underlie the results reported in this article are available from the corresponding author on reasonable request.
: Not applicable.
: All authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.