CompletedPhase 1ACTRN12610000961044

A Phase I, Open-Label, Twice Daily Dose, Pharmacokinetic Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects

Sponsor

Spinifex Pharmaceuticals Pty Ltd

Enrollment

8 participants

Start Date

Nov 18, 2010

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

This study is designed to evaluate the pharmacokinetics, safety and tolerability EMA401 in healthy elderly subjects (56 years and over) after two single oral doses of EMA401 Sodium Salt administered on the same day with a 10 hour interval between doses, for a total daily dose of 200 mg.

Eligibility

Sex: Both males and femalesMin Age: 56 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests the safety and how the body processes a new pain medication called EMA401 in healthy older adults aged 56 and over. Participants must be healthy, non-smoking males or post-menopausal females with normal blood pressure and heart function. People with significant medical conditions, liver or kidney problems, or who take certain medications are not 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 will be administered as two single oral doses of 100 mg EMA401 equivalent (4 x 25 mg capsules) on the same day with a 10 hour interval between doses, for a total daily dose of 200

EMA401 Sodium Salt will be administered as two single oral doses of 100 mg EMA401 equivalent (4 x 25 mg capsules) on the same day with a 10 hour interval between doses, for a total daily dose of 200 mg. The treatment phase of the study will last for 1 day. All subjects will be required to fast for at least 10 hours overnight prior to the first dose. The second dose will be administered 10 hours later. Subjects will be allowed a light lunch between the first and second dosing occasion. Each dose will be administered with a minimum of 240 mL of non-carbonated water. All subjects will consume no food until 4 hours post-dose.