Healthy Volunteers Clinical Trial
Official title:
Relative Bioavailability and Effect of Food on DSM265-TPGS 34% SDD Powder in Healthy Adult Subjects
Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.
The objective of this study is to compare the relative bioavailability of oral DSM265-TPGS
34% SDD formulation with that of a reference 25% SDD powder for suspension used in previous
clinical trials. Another objective of the study is to evaluate the effect of food on
bioavailability of the DSM265-TPGS 34% SDD formulation.
The current 25% SDD powder for suspension clinical formulation is a suspension which requires
reconstitution/administration in 240 mL sucralose based vehicle (for a 400 mg adult dose).
This volume is too large for paediatric patients with malaria (e.g., translates into a 30 mL
volume for 0.5-2 yr old patients); also, the dosing vehicle is not commercially viable. The
new formulation dissolves in a smaller volume of a more common vehicle, water (40 mL for 400
mg adult dose).
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