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news.IntelGenx has announced positive results from the pilot clinical trial of its antidepressant CPI-300. The preliminary results of the fasted and fed studies show that CPI-300 is equivalent to the reference product.
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The plasma profiles after administration to nine subjects demonstrate that the formulation meets the study objectives relative to area under the curve (AUC), maximum concentration (Cmax), and time-to-peak (Tmax). The 24 hour pharmacokinetic profile confirms the suitability of the newly developed formulation for the antidepressant CPI-300.
CPI-300 is a joint project between Cary Pharmaceuticals and IntelGenx. The company said that it is on track with its development timeline and project commercialization by the second half of 2009.
Horst Zerbe, CEO of IntelGenx, said: “The data clearly demonstrate the suitability of our new extended-release formulation for CPI-300. The study represents an important milestone in the development of CPI-300 and allows us to proceed without further delay to the pivotal Phase I study that will be conducted later this year.”