A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.
Spinifex Pharmaceuticals Pty Ltd
15 participants
Sep 17, 2010
Interventional
Conditions
Summary
This study is planned to investigate the effect of food on the absorption of EMA401 when EMA401 Sodium Salt is administered orally in healthy adult males (18-55 years of age inclusive) at a dose level of 50mg.
Eligibility
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Interventions
EMA401 Sodium Salt at a dose level of 50 mg EMA401 equivalent (2 x 25 mg capsules) will be administered orally as a single dose to subjects in each dosing period, either in the fasted state, following a standard high fat meal, or with 250 mL of orange juice with no added sugar. All subjects will be required to fast for at least 10 hours overnight prior to dosing. EMA401 will be administered to the following treatment groups: Fasted; two 25 mg capsules with 240 mL of non-carbonated water. High fat meal; two 25 mg capsules with 240 mL of non-carbonated water, following a standardised high fat and high caloric breakfast (50% fat and 800 to 1000 Kcal), starting 30 minutes prior to dose administration. Orange juice only: two 25 mg capsules with 250 mL of commercially available orange juice with no added sugar. All subjects will then consume no further food until 4 hours post-dose. There will be a minimum 7-day wash-out between each treatment period.
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ACTRN12610000798066