Akela Pharma has started its first EDACS product Phase I clinical trial. EDACS is company's patent pending platform technology to prevent abuse of controlled substances.
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The trial is an open-label, randomized, single-dose, cross-over study investigating the pharmacokinetics and safety of three different extended release formulations of a well-known opioid product compared to the same opioid drug immediate release formulation. The study will be carried out in 12 healthy subjects, and the results are expected to be available in third quarter of 2008.
Halvor Jaeger, CEO of Akela Pharma, said: “We believe that our platform technology is perfectly suited to meet the increasing market demand as well as regulatory pressure for abuse deterrent formulations.”
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