Not Yet RecruitingPhase 2ACTRN12609000846224

Multiple-dose pharmacokinetics and ex vivo pharmacodynamics of the fixed-dosed artemisinin based combination therapies (ACTs) of the antimalarial drugs Artequick (artemisinin-piperaquine) and Coarsucam (artesunate-amodiaquine) in healthy male Vietnamese volunteers

Multiple-dose pharmacokinetics and ex vivo pharmacodynamics of the fixed-dosed combinations of Artequick (artemisinin-piperaquine) and Coarsucam (artesunate-amodiaquine) in healthy male Vietnamese volunteers

Sponsor

Australian Department of Defence

Enrollment

44 participants

Start Date

Oct 10, 2009

Study Type

Interventional

Conditions

Characterization of the pharmacokinetics (absorption, metabolism, distribution and elimination) of the components of the antimalarial drugs Artequick and Coarsucam in healthy Vietnamese volunteers will provide important data for dose optimization and measurement of interindividual variability in plasma drug concentrations.

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.

Eligibility

Sex: MalesMin Age: 17 YearssMax Age: 40 Yearss

Inclusion Criteria5

(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 Criteria3

(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

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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 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.

Locations(1)

Hanoi, Viet Nam

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ACTRN12609000846224