Healthy Volunteers Clinical Trial
Official title:
A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers
This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.
This study was a single centre, open-label, pharmacokinetic, randomized cross-over study in
healthy male volunteers and post-menopausal women. This study was conducted over three
different cohorts as follows:
Cohort 1: Subjects received a single 800 mg (as free base) dose of five different treatment
regimes (treatments A, B, C, D and E) on five occasions.
Cohort 2: Subjects received a single 800 mg (as free base) dose of four different treatment
regimes (treatments F, G, H and I) on four occasions.
Cohort 3: Subjects received a single dose, 800mg (as free base) of prototype solution
formulation 1 (treatment J) and 400mg (as free base) of prototype solution formulation 1
(treatment K) on two occasions. The treatments were administered under the fasted state.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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