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Clinical Trial Summary

This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects


Clinical Trial Description

This is a randomized, open label, single dose, parallel group study consisting of 3 groups of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected for 480 hours after dosing.

This study will compare the relative bioavailability of the oral DSM265 50% spray dried dispersion (SDD) granules with that of a reference 25% SDD powder for suspension formulation, and evaluate the effect of food on the DSM265 50% SDD granules ;


Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02750384
Study type Interventional
Source Medicines for Malaria Venture
Contact
Status Terminated
Phase Phase 1
Start date May 2016
Completion date July 2016

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