SCLOR starts PKC study of CDT-fenofibrate
US drugmaker SCOLR Pharma has commenced pilot bioavailability testing in Canada of its immediate-release CDT-fenofibrate tablets in the treatment of elevated choesterol with results from the trial expected in late 2007.
Authorized by the Therapeutics Products Directorate, Health Canada, the trial involves 36 subjects. It is a randomized four-way, cross-over, open-label study in fasted healthy adults. The company is comparing three initial formulations of its immediate-release CDT-fenofibrate tablets to immediate-release 48mg fenofibrate controls.
Stephen Turner, SCOLR's chief technology officer, said: "this represents the initiation of our 15th clinical trial evaluating our CDT-based formulations and the first application of our oral drug-delivery platform for a potential product to control elevated cholesterol levels. Our CDT-fenofibrate formulation efforts are intended to provide us with a future product opportunity in the growing cardiovascular market and may serve as a basis for possible combination products as well."
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