CompletedPhase 1ACTRN12610000798066

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.


Sponsor

Spinifex Pharmaceuticals Pty Ltd

Enrollment

15 participants

Start Date

Sep 17, 2010

Study Type

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

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines how food affects the absorption of an experimental pain medication called EMA401 in the body. Healthy men aged 18 to 55 with normal blood pressure and no significant health conditions may be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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