Publication: Evaluation of the safety and relative bioavailability of a new dihydroartemisinin tablet formulation in healthy Thai volunteers
4
Issued Date
2007-10-01
Resource Type
ISSN
00359203
Other identifier(s)
2-s2.0-34548289920
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Transactions of the Royal Society of Tropical Medicine and Hygiene. Vol.101, No.10 (2007), 972-979
Suggested Citation
Supornchai Kongpatanakul, Somruedee Chatsiricharoenkul, Korbtham Sathirakul, Yupin Suputtamongkol, Suvajana Atipas, Suchat Watnasirichaikul, Piyapat Pongnarin, Polkit Sangvanich Evaluation of the safety and relative bioavailability of a new dihydroartemisinin tablet formulation in healthy Thai volunteers. Transactions of the Royal Society of Tropical Medicine and Hygiene. Vol.101, No.10 (2007), 972-979. doi:10.1016/j.trstmh.2007.05.010 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/24510
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Evaluation of the safety and relative bioavailability of a new dihydroartemisinin tablet formulation in healthy Thai volunteers
Abstract
A new dihydroartemisinin (DHA) tablet formulation has been developed by the Thai Government Pharmaceutical Organization (GPO). In this report, its in vitro dissolution and in vivo pharmacokinetics as well as its safety in healthy volunteers were evaluated, using the DHA tablet made by Dafra Pharma NV as a reference. A two-period crossover clinical study design was utilised. Twenty-four volunteers were randomly allocated to two sequences (12 volunteers in each) to receive a 200 mg single oral dose of either the GPO or Dafra formulation with a wash-out period of 5-7 days. In vitro, the GPO formulation dissolved more readily. In vivo, the GPO formulation had a higher maximum plasma concentration and approximately 149% (90% CI 125-179%) greater bioavailability. Both formulations were well tolerated. Interestingly, significant decreases in haemoglobin and haematocrit values (P < 0.001) were noted following administration of one dose of DHA (decrease of 0.73 g/dl haemoglobin and 2.0% haematocrit compared with baseline) or two doses of DHA (decrease of 0.95 g/dl haemoglobin and 3.3% haematocrit compared with baseline). The second dose was associated with additional toxicity compared with one dose with regard to haematocrit (P < 0.001) but not haemoglobin. This finding warrants further investigation, since the drug will be used for the treatment of malaria in which anaemia is a consequence. © 2007 Royal Society of Tropical Medicine and Hygiene.