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Authors
Tarning, Joel
Hanboonkunupakarn, Borimas
Hoglund, Richard M.
Chotivanich, Kesinee
Mukaka, Mavuto
Pukrittayakamee, Sasithon
Day, Nicholas P. J.
White, Nicholas J.
Dondorp, Arjen M.
Jittamala, Podjanee
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Clinical Trials BETA
Clinical trials referenced in this document:
tctr20170907002 at Thai Clinical Trials RegistryDocuments that mention this clinical trial
Safety and pharmacokinetic properties of a new formulation of parenteral artesunate in healthy Thai volunteers
https://doi.org/10.1186/s12936-024-05085-9
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Funding
Funding for this research was provided by:
Wellcome Trust (220211, 220211, 220211, 220211, 220211)
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Article History
Received: 8 May 2024
Accepted: 17 August 2024
First Online: 3 October 2024
Declarations
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: The protocol and related documents were approved by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University (#MUTM 2017-056-01) and Oxford Tropical Research Ethics Committee, University of Oxford (#25-17). Guilin Pharmaceutical Co., Ltd. (Guilin) P.R. China was the trial sponsor. The trial was conducted in compliance with the protocol, GCP, standard operating procedures (SOPs), study specific work instructions, and any applicable regulatory requirements. Clinical study monitors, under contract with the sponsor, reviewed all necessary documentations and practices. All volunteers were able to read the related documents, discussed with investigators, and signed informed consent prior to the screening and enrolment in the study. The study was registered to clinicaltrials.gov (#TCTR20170907002).
: All authors declare that they have no competing interests.
