A Phase I, pharmacokinetic trial, in healthy Asian and Caucasian volunteers for investigating the pharmacokinetic profiles of Eurartesim (trademark) (40 mg Dihydroartemisinin/320 mg Piperaquine Phosphate)
A phase 1 pharmacokinetic trial in healthy Asian and Caucasian volunteers, investigating the pharmacokinetic profile of an Anti-Malarial drug - 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP).
CPR Pharma Services Pty Ltd
20 participants
Feb 15, 2010
Interventional
Conditions
Summary
The purpose of this study is to test the safety of the drug Eurartesim (trademarked). The drug is to be used for the treatment of uncomplicated Plasmodium Falciparum (a type of malaria, a mosquito borne infectious disease). A number of safety studies have been completed for this new drug, but the company requires more information about what happens when taking this drug in certain groups of people, including the differences between men and women, and the differences between asian and caucasian (western) people and the difference in body weights ( particularly people weighing less than 65 kg and those weighing more than 65kg). The study is to be conducted in helathy people to comapre how the drug behaves in these groups.
Eligibility
Plain Language Summary
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Interventions
Eurartesim (trademark) is a fixed dose combination tablet for oral administration. Each tablet contains 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP) On the study each subject recieves either three or four tablets daily for three consecutive days. The tablets are to be administered following a light breakfast (30 g cornflakes and 250 mL fullfat milk). The number of tablets administered is calculated using the subjects body weight - subjects weighing less than 75 kg are prescribed three tablets and subjects weighing greater than 75 kg are prescribed four tablets.
Locations(1)
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ACTRN12610000178044