None listed
Conditions
Brief summary
Although Artequick (artemisinin-piperaquine) and Coarcusam (artesunate-amodiaquine) are currently being tested for efficacy in the treatment of uncomplicated falciparum malaria there is a paucity of information on the pharmacokinetics of the two artemisinin based combination therapies. The purpose of the study is to determine the pharmacokinetics and ex vivo antimalarial activity of the fixed-dosed combinations of Artequick and Coarsucam in healthy Vietnamese volunteers. The pharmacokinetic data will be used for dose optimization and to measure the interindividual variability in plasma drug concentrations. The ex vivo antimalarial assessment of the two ACTs will provide information on the relationship between blood drug concentrations and parasiticidal effect, in vitro, without the confounding factor of immunity.
Interventions
Two groups of 22 healthy male Vietnamese volunteers will be recruited to receive 3-day courses of either Artequick or Coarsucam. Group 1 healthy volunteers (n=22) will be administered a daily dose of two tablets of Artequick (each tablet contains 62.5 mg artemisinin and 375 mg piperaquine) for 3 days. Group 2 healthy volunteers (n=22) will be administered a daily dose of two tablets of Coarsucam (each tablet contains 100 mg artesunate and 270 mg amodiaquine) for 3 days.
Sponsors
Australian Department of Defence
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
17 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria (i) Males: 17-40 years (ii) Normal clinical parameters: medical history, physical examination (iii) Normal haematological and biochemical indices, and electrocardiogram (iv) The volunteer is willing not to drink alcohol and caffeine containing beverages one day before and after drug administration (v) Able to understand and willing to provide written informed consent
Exclusion criteria
Exclusion criteria (i) A history of serious past medical diseases (ii) A history of drug or alcohol abuse (iii) Use of regular medications including prescribed and natural therapies
Outcome results
None listed