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
Phase 2
- 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.Infection - Other infectious diseases
- Registration Number
- ACTRN12609000846224
- Lead Sponsor
- Australian Department of Defence
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 44
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method