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Authors
Lacombe, Olivier https://orcid.org/0009-0001-9238-7702
Pletan, Yannick
Grouin, Jean-Marie
Brennan, Aislinn
Giré, Olivier
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05026567 at ClinicalTrials.govDocuments that mention this clinical trial
Relative Bioavailability Study of Midazolam Intramuscularly Administered with the Needle-Free Auto-Injector ZENEO® in Healthy Adults
https://doi.org/10.1007/s40120-024-00627-4
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Article History
Received: 19 March 2024
Accepted: 29 April 2024
First Online: 28 May 2024
Declarations
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: Olivier Lacombe is an employee of CROSSJECT SA; Yannick Pletan has/held leadership positions at, or has/had advisory roles at DEINOVE, NH THERAGUIX, NFL Biotechnologies, CROSSJECT SA, OTR3, ACTICOR-BIOTECH, and TREEFROG Therapeutics; Jean-Marie Grouin is a consultant for CROSSJECT SA. Co-founder of One Minus Beta, a company that provides statistical and methodological consulting in the areas of drug and medical device development. He is a Professor of Statistics at the University of Rouen and researcher at Inserm Unit 1219, France; Aislinn Brennan is an employee of the CRO contracted by CROSSJECT SA; Olivier Giré holds a leadership position at CROSSJECT SA.
: The study protocol was approved by the South African competent authority (i.e., the South African Health Products Regulatory Authority, Pretoria, South Africa) and by an independent ethics committee, (i.e., the Health Sciences Research Ethics Committee, Bloemfontein, South Africa). The study was conducted in accordance with the protocol, the Declaration of Helsinki, Good Clinical Practice E6(R2), the European Union Clinical Trials Directive, and with the applicable local regulatory requirements. All participants provided written informed consent before study inclusion.
